Trial Outcomes & Findings for A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice (NCT NCT03532932)
NCT ID: NCT03532932
Last Updated: 2024-03-29
Results Overview
Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \[SB\] +/- STER+/-standard therapy\[ST\]),\>5ASA2(without \[w/o\] STER),\>5ASA3(5-ASA→STER+/-ST),\>5ASA4(5-ASA→IS),\>5ASA 5(5-ASA→5-ASA+/-IS),\>5ASA6(5-ASA→ NOTR),\>5ASA7(5-ASA),\>NOTR1(NOTR→Biologics \[BIO\]+/-ST+/-STER),\>NOTR 2(TR→ST+/-STER),\>NOTR 3(NOTR),\>IS1(IS→SB+STER+/-ST),\>IS2(IS→SB+ST w/o STER),\>IS 3(IS→STER+/-ST),\>IS4(IS→5-ASA),\>IS5(IS→NOTR),\>IS6(IS→5-ASA+IS),\>IS7(IS mono),\>IS+5ASA1(IS+5-ASA→SB +/-ST),\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\>IS+5ASA3(IS+5-ASA→STER+/-ST),\>IS+5ASA4(IS+5-ASA→NOTR),\>IS+5ASA5(IS+5-ASA→IS),\>IS+5ASA6(IS+5-ASA→5-ASA),\>IS+5ASA7(IS+5-ASA),\>BIO1(SB+/-STER+/-ST→withdrawal \[w/d\] of SB+ST+/-STER),\>BIO2(SB+/-STER+/-ST),\>BIO3(SB+/-STER+/-ST→NOTR),\>BIO4(SB+/-STER+/-ST→SB mono),\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\>STER2(STER+/-ST→w/d of STER+ST),\>STER3(STER+/-ST→SB+STER+/-ST),\>STER4(STER+/-ST→NOTR),\>STER5(STER+/-ST).
Recruitment status
COMPLETED
Target enrollment
1990 participants
Primary outcome timeframe
From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Results posted on
2024-03-29
Participant Flow
Participants took part in the study at the 36 investigative sites in Russia, Belarus and Kazakhstan from 20 July 2018 to 08 November 2021.
Participants diagnosed with moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) were observed retrospectively within 2 years before enrollment and prospectively one year after enrollment. A total of 1990 participants were enrolled (signed informed consent) into the study, of which 89 were screen failures. 1901 participants started the study and were analyzed in the study.
Participant milestones
| Measure |
UC Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
CD Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
1214
|
687
|
|
Overall Study
COMPLETED
|
1140
|
615
|
|
Overall Study
NOT COMPLETED
|
74
|
72
|
Reasons for withdrawal
| Measure |
UC Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
CD Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Overall Study
Protocol Deviation
|
33
|
31
|
|
Overall Study
Appearance of Exclusion Criteria
|
9
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
15
|
9
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Other
|
11
|
16
|
Baseline Characteristics
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
Baseline characteristics by cohort
| Measure |
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
Total
n=1901 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.44 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
36.44 years
STANDARD_DEVIATION 13.90 • n=7 Participants
|
39.63 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
582 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
923 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
632 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
978 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Russian
|
858 Participants
n=5 Participants
|
574 Participants
n=7 Participants
|
1432 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Tartarian
|
133 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ukrainian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baskirian
|
24 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chuvash
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Belarusian
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Kazakh
|
88 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
81 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Kazakhstan
|
121 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
1063 Participants
n=5 Participants
|
643 Participants
n=7 Participants
|
1706 Participants
n=5 Participants
|
|
Employment Status
Employed
|
702 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
1045 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
287 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
|
Employment Status
Pensioner
|
133 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Employment Status
Student
|
53 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Employment Status
Other
|
39 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Disability
Had Disability
|
392 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
733 Participants
n=5 Participants
|
|
Disability
Had no Disability
|
822 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
1168 Participants
n=5 Participants
|
|
Smoking Status
Non-smoker and Never Smoked Before
|
937 Participants
n=5 Participants
|
519 Participants
n=7 Participants
|
1456 Participants
n=5 Participants
|
|
Smoking Status
Ex-smoker
|
211 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
66 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Age at Disease Onset
|
34.46 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
30.79 years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
33.14 years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Family History of Inflammatory Bowel Disease (IBD)
With IBD History
|
34 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Family History of Inflammatory Bowel Disease (IBD)
Without IBD History
|
1180 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
1846 Participants
n=5 Participants
|
|
Clinical Course of IBD
Acute Form (Less than 6 months Since the Onset of the Illness)
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Clinical Course of IBD
Chronic Continuous Form (Absence of Remission Longer Than 6 months Despite Adequate Treatment)
|
362 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
|
Clinical Course of IBD
Chronic Relapsing Course (With Remission Periods Longer Than 6 months)
|
839 Participants
n=5 Participants
|
385 Participants
n=7 Participants
|
1224 Participants
n=5 Participants
|
|
Complications of IBD
Had Complications of IBD
|
111 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Complications of IBD
Had no Complications of IBD
|
1103 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
1473 Participants
n=5 Participants
|
|
Extraintestinal Manifestation (EIM)
|
295 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Had Medical History
|
274 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \[SB\] +/- STER+/-standard therapy\[ST\]),\>5ASA2(without \[w/o\] STER),\>5ASA3(5-ASA→STER+/-ST),\>5ASA4(5-ASA→IS),\>5ASA 5(5-ASA→5-ASA+/-IS),\>5ASA6(5-ASA→ NOTR),\>5ASA7(5-ASA),\>NOTR1(NOTR→Biologics \[BIO\]+/-ST+/-STER),\>NOTR 2(TR→ST+/-STER),\>NOTR 3(NOTR),\>IS1(IS→SB+STER+/-ST),\>IS2(IS→SB+ST w/o STER),\>IS 3(IS→STER+/-ST),\>IS4(IS→5-ASA),\>IS5(IS→NOTR),\>IS6(IS→5-ASA+IS),\>IS7(IS mono),\>IS+5ASA1(IS+5-ASA→SB +/-ST),\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\>IS+5ASA3(IS+5-ASA→STER+/-ST),\>IS+5ASA4(IS+5-ASA→NOTR),\>IS+5ASA5(IS+5-ASA→IS),\>IS+5ASA6(IS+5-ASA→5-ASA),\>IS+5ASA7(IS+5-ASA),\>BIO1(SB+/-STER+/-ST→withdrawal \[w/d\] of SB+ST+/-STER),\>BIO2(SB+/-STER+/-ST),\>BIO3(SB+/-STER+/-ST→NOTR),\>BIO4(SB+/-STER+/-ST→SB mono),\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\>STER2(STER+/-ST→w/d of STER+ST),\>STER3(STER+/-ST→SB+STER+/-ST),\>STER4(STER+/-ST→NOTR),\>STER5(STER+/-ST).
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
Greater than (>) 5-aminosalicylic acid (5ASA) 1
|
16 Participants
|
33 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>5ASA 2
|
14 Participants
|
38 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
> 5ASA 3
|
30 Participants
|
192 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>5ASA 4
|
5 Participants
|
9 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>5ASA 5
|
7 Participants
|
46 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>5ASA 6
|
8 Participants
|
22 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>5ASA 7
|
5 Participants
|
73 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>BIO 1
|
20 Participants
|
28 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>BIO 2
|
96 Participants
|
71 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>BIO 3
|
22 Participants
|
7 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>BIO 4
|
19 Participants
|
9 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>Immunosuppressive (IS) 1
|
13 Participants
|
2 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 2
|
20 Participants
|
6 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 3
|
6 Participants
|
3 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 4
|
3 Participants
|
2 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 5
|
5 Participants
|
1 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 6
|
3 Participants
|
3 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS 7
|
9 Participants
|
1 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 1
|
8 Participants
|
8 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 2
|
9 Participants
|
15 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 3
|
10 Participants
|
22 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 4
|
7 Participants
|
6 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 5
|
3 Participants
|
3 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 6
|
5 Participants
|
8 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>IS+5ASA 7
|
9 Participants
|
22 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>No IBD Therapy (NO TR) 1
|
54 Participants
|
69 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>NO TR 2
|
76 Participants
|
217 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>NO TR 3
|
0 Participants
|
8 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>Steroids (STER) 1
|
35 Participants
|
45 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>STER 2
|
28 Participants
|
95 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>STER 3
|
14 Participants
|
13 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>STER 4
|
6 Participants
|
14 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
>STER 5
|
2 Participants
|
8 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
Pattern with combination of biologics (BIO COMB)
|
44 Participants
|
35 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
Vedolizumab
|
57 Participants
|
58 Participants
|
|
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
Other
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Within 1 year prior to Baseline (Visit 1)Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CD Participants
n=664 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants Stratified by Location of Disease
Lining of the Rectum
|
0 Participants
|
107 Participants
|
|
Number of Participants Stratified by Location of Disease
Left Side of Colon
|
0 Participants
|
623 Participants
|
|
Number of Participants Stratified by Location of Disease
Ileum
|
146 Participants
|
0 Participants
|
|
Number of Participants Stratified by Location of Disease
Colon
|
183 Participants
|
750 Participants
|
|
Number of Participants Stratified by Location of Disease
Ileum and Colon
|
331 Participants
|
0 Participants
|
|
Number of Participants Stratified by Location of Disease
Upper Gastrointestinal Tract
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective periodPopulation: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified visits.
Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \>10 was severe.
Outcome measures
| Measure |
CD Participants
n=640 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1153 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants Stratified by Disease Severity
Visit 2: Remission
|
339 Participants
|
576 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 3: Remission
|
361 Participants
|
614 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 1: Remission
|
322 Participants
|
211 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 1: Mild
|
166 Participants
|
406 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 1: Moderate
|
144 Participants
|
522 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 1: Severe
|
8 Participants
|
14 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 2: Mild
|
119 Participants
|
300 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 2: Moderate
|
43 Participants
|
105 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 2: Severe
|
1 Participants
|
3 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 3: Mild
|
103 Participants
|
250 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 3: Moderate
|
34 Participants
|
81 Participants
|
|
Number of Participants Stratified by Disease Severity
Visit 3: Severe
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline Visit (Day 1) up to 12 monthsPopulation: FAS included those participants who signed the informed consent form and were analyzed in the study.
Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
Biomarkers
|
662 Participants
|
1151 Participants
|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
Endoscopy
|
656 Participants
|
1188 Participants
|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
Biopsy
|
453 Participants
|
901 Participants
|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
X-ray Examination
|
239 Participants
|
206 Participants
|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
MRI Examination
|
369 Participants
|
138 Participants
|
|
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
Ultrasound Examination
|
254 Participants
|
283 Participants
|
SECONDARY outcome
Timeframe: From Baseline Visit (Day 1) up to 12 monthsPopulation: FAS included those participants who signed the informed consent form and were analyzed in the study.
Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation.
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
Biomarkers
|
6.74 assessments
Standard Deviation 7.11
|
4.52 assessments
Standard Deviation 4.88
|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
Endoscopy
|
2.31 assessments
Standard Deviation 1.39
|
2.60 assessments
Standard Deviation 1.57
|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
Biopsy
|
1.11 assessments
Standard Deviation 1.16
|
1.38 assessments
Standard Deviation 1.24
|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
X-ray Examination
|
0.62 assessments
Standard Deviation 1.13
|
0.23 assessments
Standard Deviation 0.59
|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
MRI Examination
|
1.10 assessments
Standard Deviation 1.44
|
0.15 assessments
Standard Deviation 0.46
|
|
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
Ultrasound Examination
|
1.10 assessments
Standard Deviation 1.95
|
0.53 assessments
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective periodPopulation: FAS included those participants who signed the informed consent form and were analyzed in the study.
The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \>10 was severe activity. Higher scores indicating higher disease activity.
Outcome measures
| Measure |
CD Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 1: Remission
|
—
|
18.30 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 1: Mild Activity
|
—
|
35.21 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 1: Moderate Activity
|
—
|
45.27 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 1: Severe Activity
|
—
|
1.21 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 2: Remission
|
—
|
58.54 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 2: Mild Activity
|
—
|
30.49 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 3: Remission
|
—
|
64.97 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 2: Moderate Activity
|
—
|
10.67 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 2: Severe Activity
|
—
|
0.30 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 3: Mild Activity
|
—
|
26.46 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 3: Moderate Activity
|
—
|
8.57 percentage of participants
|
|
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
Visit 3: Severe Activity
|
—
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective periodPopulation: FAS included those participants who signed the informed consent form and were analyzed in the study.
HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \>16 was severe activity. Higher scores indicating higher disease activity.
Outcome measures
| Measure |
CD Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=687 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 1: Severe Activity
|
—
|
1.25 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 1: Remission
|
—
|
50.31 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 1: Mild Activity
|
—
|
25.94 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 1: Moderate Activity
|
—
|
22.50 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 2: Remission
|
—
|
67.53 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 2: Mild Activity
|
—
|
23.71 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 2: Moderate Activity
|
—
|
8.57 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 2: Severe Activity
|
—
|
0.20 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 3: Remission
|
—
|
72.20 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 3: Mild Activity
|
—
|
20.60 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 3: Moderate Activity
|
—
|
6.80 percentage of participants
|
|
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
Visit 3: Severe Activity
|
—
|
0.40 percentage of participants
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy
|
670 Participants
|
1203 Participants
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
CD Participants
n=35 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=35 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
If an Exacerbation or Deterioration Developed
|
1 Participants
Interval 21.0 to
|
0 Participants
Interval 15.0 to
|
|
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
Every 3 months, as well as in the Development of Exacerbation or Deterioration
|
10 Participants
Interval 22.0 to
|
14 Participants
Interval 19.2 to
|
|
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
Every six months, as well as When the Exacerbation or Deterioration
|
15 Participants
Interval 22.4 to
|
11 Participants
Interval 21.4 to
|
|
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
Once a year, as well as in the Case of the Development of Exacerbation or Deteriorations
|
8 Participants
Interval 24.4 to
|
9 Participants
Interval 23.7 to
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories.
Treat to target (T2T) approach was used for assessment of treatment goals. A "Treat to target" approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \[CRP\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.
Outcome measures
| Measure |
CD Participants
n=35 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=35 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Percentage of Participants Stratified by Achieving the Treatment Goals
Clinical Remission
|
70.3 percentage of participants
|
81.3 percentage of participants
|
|
Percentage of Participants Stratified by Achieving the Treatment Goals
Endoscopic Remission
|
50.6 percentage of participants
|
61.2 percentage of participants
|
|
Percentage of Participants Stratified by Achieving the Treatment Goals
Histological Remission
|
27.4 percentage of participants
|
29.8 percentage of participants
|
|
Percentage of Participants Stratified by Achieving the Treatment Goals
Biomarker Remission
|
68.1 percentage of participants
|
75.9 percentage of participants
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
"Other" challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).
Outcome measures
| Measure |
CD Participants
n=35 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=35 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Difficulties or Inaccessibility of Colonoscopy
|
28.6 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Unwillingness to Undergo Colonoscopy
|
45.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Participant's Failure to Follow Visit Scheduled With Physician
|
40.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Participant's Non-compliance With Drug Therapy
|
51.4 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Resistant Course of Disease
|
71.4 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Difficulties or Unavailability of Certain Drugs
|
57.1 percentage of participants
|
65.7 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Workload of Doctor
|
22.9 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Lack of Participants Record System and Monitoring
|
22.9 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Other
|
20.0 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD
Hospitalizations due to Complications
|
3.06 percentage of participants
|
2.14 percentage of participants
|
|
Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD
IBD Related Surgeries
|
0.73 percentage of participants
|
0.33 percentage of participants
|
|
Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD
IBD Related Disability
|
47.74 percentage of participants
|
29.57 percentage of participants
|
SECONDARY outcome
Timeframe: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, number analyzed signifies participants who were evaluable for given categories.
Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.
Outcome measures
| Measure |
CD Participants
n=687 Participants
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
UC Participants
n=1214 Participants
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Aggravation
|
0.58 percentage of participants
|
0.58 percentage of participants
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Intestinal Bleeding
|
—
|
0.49 percentage of participants
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Colon Perforation
|
0.15 percentage of participants
|
0.08 percentage of participants
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Other
|
1.16 percentage of participants
|
0.99 percentage of participants
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Internal Fistulas
|
0.15 percentage of participants
|
—
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Abdominal Cavity Infiltrate
|
0.15 percentage of participants
|
—
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Interintestinal or Intraabdominal Abscess
|
0.29 percentage of participants
|
—
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Strictures in the gastrointestinal tract
|
1.16 percentage of participants
|
—
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Surgical Treatment by Indication: Anal Fissures
|
0.15 percentage of participants
|
—
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Type of Surgeries: Emergency
|
0.29 percentage of participants
|
0.16 percentage of participants
|
|
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Type of Surgeries: Planned
|
0.58 percentage of participants
|
0.25 percentage of participants
|
Adverse Events
UC Participants
Serious events: 146 serious events
Other events: 48 other events
Deaths: 3 deaths
CD Participants
Serious events: 84 serious events
Other events: 31 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
UC Participants
n=1214 participants at risk
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
CD Participants
n=687 participants at risk
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
10.2%
124/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Proctitis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Abscess intestinal
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Pneumonia
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Anal abscess
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Acute hepatitis C
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
COVID-19
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Nervous system disorders
Speech disorder
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Reproductive system and breast disorders
Cervical leukoplakia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Surgical and medical procedures
Colitis ulcerative
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
8.2%
56/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.44%
3/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Surgical and medical procedures
Small intestinal resection
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Surgical and medical procedures
Ileectomy
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Vascular disorders
Takayasu's arteritis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
Other adverse events
| Measure |
UC Participants
n=1214 participants at risk
Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
CD Participants
n=687 participants at risk
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.58%
7/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.73%
5/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.33%
4/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.49%
6/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.44%
3/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
General disorders
Gait disturbance
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
General disorders
Drug resistance
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
General disorders
Drug intolerance
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
General disorders
Loss of therapeutic response
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Immune system disorders
Bartholin's abscess
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Tuberculosis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Investigations
Transaminases increased
|
0.25%
3/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Metabolism and nutrition disorders
Cell death
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Nervous system disorders
Dizziness
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Nervous system disorders
Headache
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Psychiatric disorders
Insomnia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Reproductive system and breast disorders
Cervical leukoplakia
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Surgical and medical procedures
Abscess drainage
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.00%
0/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.29%
2/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
General disorders
Drug ineffective
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Hepatobiliary disorders
Drug induced liver injury
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.44%
3/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.16%
2/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Herpes zoster
|
0.08%
1/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia totalis
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/1214 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
0.15%
1/687 • Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER