Trial Outcomes & Findings for A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants (NCT NCT03710486)

NCT ID: NCT03710486

Last Updated: 2024-05-30

Results Overview

Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

• Recruitment status: COMPLETED
• Target enrollment: 409 participants
• Primary outcome timeframe: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
• Results posted on: 2024-05-30

Participant Flow

Participants took part in the study at 25 investigative sites in Spain and Portugal from 19 February 2019 to 21 February 2022.

Participants diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) and who initiated first or second line biologic treatment with vedolizumab or another biologic between January 2017 until date of site initiation were enrolled and observed retrospectively in this medical chart review study.

Participant milestones

Measure	Cohort 1: Vedolizumab Participants diagnosed with UC or CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2: Anti-TNF Alpha Participants diagnosed with UC or CD, who had initiated first or second-line treatment with another biologic treatment (anti-tumour necrosis factor-alpha \[TNF alpha\]: infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Overall Study STARTED	185	224
Overall Study COMPLETED	172	212
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Measure	Cohort 1: Vedolizumab Participants diagnosed with UC or CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2: Anti-TNF Alpha Participants diagnosed with UC or CD, who had initiated first or second-line treatment with another biologic treatment (anti-tumour necrosis factor-alpha \[TNF alpha\]: infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Overall Study Lost to Follow-up (at least 12 months)	13	10
Overall Study Missing	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cohort 1: Vedolizumab n=185 Participants Participants diagnosed with UC or CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2: Anti-TNF Alpha n=224 Participants Participants diagnosed with UC or CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Total n=409 Participants Total of all reporting groups
Age, Customized 18 to 92 Years	185 Participants n=185 Participants	224 Participants n=224 Participants	409 Participants n=409 Participants
Sex: Female, Male Female	81 Participants n=185 Participants	85 Participants n=224 Participants	166 Participants n=409 Participants
Sex: Female, Male Male	104 Participants n=185 Participants	139 Participants n=224 Participants	243 Participants n=409 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	159 Participants n=185 Participants	199 Participants n=224 Participants	358 Participants n=409 Participants
Region of Enrollment Portugal	26 Participants n=185 Participants	25 Participants n=224 Participants	51 Participants n=409 Participants
Body Mass Index (BMI)	24.8 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4.3 • n=143 Participants • Here, "number analyzed" signifies participants for whom BMI data was available at the baseline.	24.5 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4.0 • n=176 Participants • Here, "number analyzed" signifies participants for whom BMI data was available at the baseline.	24.6 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4.2 • n=319 Participants • Here, "number analyzed" signifies participants for whom BMI data was available at the baseline.
Smoking Status Never Smoked	74 Participants n=161 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	113 Participants n=214 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	187 Participants n=375 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.
Smoking Status Former Smoker	61 Participants n=161 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	66 Participants n=214 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	127 Participants n=375 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.
Smoking Status Current Smoker	26 Participants n=161 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	35 Participants n=214 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.	61 Participants n=375 Participants • Here, "number analyzed" signifies participants for whom smoking status data was available at the baseline.
Treatment History for CD Participants Corticosteroids	37 Participants n=69 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	61 Participants n=115 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	98 Participants n=184 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.
Treatment History for CD Participants Immunomodulators	36 Participants n=69 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	63 Participants n=115 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	99 Participants n=184 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.
Treatment History for CD Participants Antibiotics	7 Participants n=69 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	17 Participants n=115 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	24 Participants n=184 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.
Treatment History for CD Participants 5-aminosalicylic acid (5-ASA)	28 Participants n=69 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	34 Participants n=115 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	62 Participants n=184 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.
Treatment History for CD Participants Other	14 Participants n=69 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	46 Participants n=115 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.	60 Participants n=184 Participants • Here, "number analyzed" signifies CD participants for whom data for treatment history was available at the baseline.
Treatment History for UC Participants Corticosteroids	57 Participants n=96 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	66 Participants n=94 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	123 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.
Treatment History for UC Participants Corticosteroids Immunomodulators	42 Participants n=96 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	44 Participants n=94 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	86 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.
Treatment History for UC Participants Immunomodulators	4 Participants n=96 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	8 Participants n=94 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	12 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.
Treatment History for UC Participants 5-ASA	68 Participants n=96 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	73 Participants n=94 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	141 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.
Treatment History for UC Participants Other	25 Participants n=96 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	27 Participants n=94 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.	52 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for treatment history was available at the baseline.
Type of Inflammatory Bowel Disease (IBD) CD	83 Participants n=185 Participants	127 Participants n=224 Participants	210 Participants n=409 Participants
Type of Inflammatory Bowel Disease (IBD) UC	102 Participants n=185 Participants	97 Participants n=224 Participants	199 Participants n=409 Participants
Age at First Ever CD Diagnosis	47.6 years STANDARD_DEVIATION 17.3 • n=60 Participants • Here, "number analyzed" signifies CD participants for whom data for age at first ever diagnosis was available at the baseline.	35.0 years STANDARD_DEVIATION 16.0 • n=107 Participants • Here, "number analyzed" signifies CD participants for whom data for age at first ever diagnosis was available at the baseline.	39.5 years STANDARD_DEVIATION 17.5 • n=167 Participants • Here, "number analyzed" signifies CD participants for whom data for age at first ever diagnosis was available at the baseline.
Age at First Ever UC diagnosis	44.6 years STANDARD_DEVIATION 19.2 • n=78 Participants • Here, "number analyzed" signifies UC participants for whom data for age at first ever diagnosis was available at the baseline.	37.6 years STANDARD_DEVIATION 14.8 • n=76 Participants • Here, "number analyzed" signifies UC participants for whom data for age at first ever diagnosis was available at the baseline.	41.1 years STANDARD_DEVIATION 17.5 • n=154 Participants • Here, "number analyzed" signifies UC participants for whom data for age at first ever diagnosis was available at the baseline.
Location of Intestinal Involvement at Diagnosis in CD Participants Ileal	51 Participants n=83 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	53 Participants n=127 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	104 Participants n=210 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.
Location of Intestinal Involvement at Diagnosis in CD Participants Colonic	10 Participants n=83 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	17 Participants n=127 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	27 Participants n=210 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.
Location of Intestinal Involvement at Diagnosis in CD Participants Upper Gastrointestinal Tract	8 Participants n=83 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	13 Participants n=127 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	21 Participants n=210 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.
Location of Intestinal Involvement at Diagnosis in CD Participants Ileocolonic	22 Participants n=83 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	55 Participants n=127 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.	77 Participants n=210 Participants • Here, "number analyzed" signifies CD participants for whom data for location of intestinal involvement at diagnosis was available at the baseline.
Location of UC at Diagnosis Proctitis/proctosigmoiditis	23 Participants n=98 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	17 Participants n=92 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	40 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.
Location of UC at Diagnosis Left-sided (Distal to Splenic flexure)	35 Participants n=98 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	31 Participants n=92 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	66 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.
Location of UC at Diagnosis Extensive Colitis (Proximal to Hepatic Flexure)	40 Participants n=98 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	44 Participants n=92 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.	84 Participants n=190 Participants • Here, "number analyzed" signifies UC participants for whom data for location of UC diagnosis was available at the baseline.
Type of Active Fistulas at Diagnosis in CD Participants Anal	3 Participants n=7 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	17 Participants n=24 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	20 Participants n=31 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.
Type of Active Fistulas at Diagnosis in CD Participants Rectovaginal	0 Participants n=7 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	2 Participants n=24 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	2 Participants n=31 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.
Type of Active Fistulas at Diagnosis in CD Participants Enterocutaneous	2 Participants n=7 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	2 Participants n=24 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	4 Participants n=31 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.
Type of Active Fistulas at Diagnosis in CD Participants Internal	2 Participants n=7 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	4 Participants n=24 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.	6 Participants n=31 Participants • Here, "number analyzed" signifies CD participants for whom data for type of active fistulas at diagnosis was available at the baseline.
Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Inflammatory	37 Participants n=79 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	74 Participants n=120 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	111 Participants n=199 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.
Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Stricturing	36 Participants n=79 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	35 Participants n=120 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	71 Participants n=199 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.
Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Penetrating	9 Participants n=79 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	19 Participants n=120 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	28 Participants n=199 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.
Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Anal	2 Participants n=79 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	12 Participants n=120 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.	14 Participants n=199 Participants • Here, "number analyzed" signifies CD participants for whom data for type of disease behavior at diagnosis inflammatory was available at the baseline.
Participants With and Without Active Fistulas at Diagnosis in CD Participants Participants with Active Fistulas at Diagnosis in CD Participants	8 Participants n=75 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.	27 Participants n=107 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.	35 Participants n=182 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.
Participants With and Without Active Fistulas at Diagnosis in CD Participants Participants Without Active Fistulas at Diagnosis in CD Participants	67 Participants n=75 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.	80 Participants n=107 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.	147 Participants n=182 Participants • Here, "number analyzed" signifies CD participants for whom data for active fistulas at diagnosis was available at the baseline.
Number of Fistulas in CD Participants	1.4 number of fistulas STANDARD_DEVIATION 0.8 • n=7 Participants • Here, "number analyzed" signifies CD participants for whom data for number of fistulas at diagnosis was available at the baseline.	1.2 number of fistulas STANDARD_DEVIATION 0.4 • n=19 Participants • Here, "number analyzed" signifies CD participants for whom data for number of fistulas at diagnosis was available at the baseline.	1.3 number of fistulas STANDARD_DEVIATION 0.5 • n=26 Participants • Here, "number analyzed" signifies CD participants for whom data for number of fistulas at diagnosis was available at the baseline.

PRIMARY outcome

Timeframe: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With One or More Treatment Intensifications for CD Participants	30.7 percentage of participants	42.1 percentage of participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=102 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With One or More Treatment Intensifications for UC Participants	43.5 percentage of participants	39.5 percentage of participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable for specified categories of this outcome measure.

Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=17 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=38 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Absence of primary response	6 Participants	6 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Lost of response	2 Participants	13 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Partial response	2 Participants	3 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Adverse event	4 Participants	10 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Remission	0 Participants	1 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Other reasons	3 Participants	5 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in first-line group · Missing	0 Participants	0 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Absence of primary response	6 Participants	2 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Lost of response	1 Participants	7 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Partial response	0 Participants	1 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Adverse event	0 Participants	6 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Remission	0 Participants	0 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Other reasons	2 Participants	4 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in CD Participants Participants discontinued treatment in second-line group · Missing	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable for specified categories of this outcome measure.

Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=19 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=29 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Absence of primary response	8 Participants	9 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Lost of response	6 Participants	6 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Partial response	0 Participants	2 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Adverse event	0 Participants	3 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Remission	0 Participants	3 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Other reasons	4 Participants	6 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in first-line group · Missing	1 Participants	0 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Absence of primary response	3 Participants	2 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Lost of response	5 Participants	8 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Partial response	1 Participants	3 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Adverse event	1 Participants	0 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Remission	1 Participants	1 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Other reasons	2 Participants	1 Participants	—	—
Number of Participants With Reasons for Treatment Modifications in UC Participants Participants discontinued treatment in second-line group · Missing	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants Who Discontinued Index Therapy for CD Participants	38.8 percentage of participants	49.3 percentage of participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=102 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants Who Discontinued Index Therapy for UC Participants	39.6 percentage of participants	50.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group.

Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=26 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=31 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation	20 Participants	16 Participants	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group.

Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab [UC only], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=20 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=16 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Time to Switching for Vedolizumab Participants	11.29 months Interval 6.49 to 14.23	8.62 months Interval 6.55 to 16.16	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=26 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=58 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Time to Discontinuation for CD Participants	7.1 months Interval 5.6 to 12.5	10.7 months Interval 7.1 to 20.2	—	—

PRIMARY outcome

Timeframe: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=32 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=44 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Time to Discontinuation for UC Participants	9.0 months Interval 6.1 to 15.6	10.1 months Interval 5.7 to 15.2	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the statistical analysis plan (SAP), the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (<=) 4 or reduction of greater than or equal to (>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=62 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=94 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Response at 14 Weeks for CD Participants	68.1 percentage of participants Interval 4.1 to	88.2 percentage of participants Interval 3.7 to	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of <=4 or reduction of >=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=75 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=119 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Response at 52 Weeks for CD Participants	74.8 percentage of participants Interval 2.3 to	69.8 percentage of participants Interval 2.5 to	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (<) 4 or reduction of >= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=81 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=78 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Response at 14 Weeks for UC Participants	81.2 percentage of participants Interval 2.3 to	80.5 percentage of participants Interval 2.5 to	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of <4 or reduction of >= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=93 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=93 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Response at 52 Weeks for UC Participants	75.6 percentage of participants Interval 7.3 to	73.2 percentage of participants Interval 6.0 to	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of <=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=62 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=94 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants	56.2 percentage of participants Interval 7.3 to	79.3 percentage of participants Interval 6.0 to	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of <=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=75 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=119 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants	51.3 percentage of participants	66.5 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of <2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=81 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=78 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants	52.2 percentage of participants	54.7 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of <2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=93 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=93 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants	56.6 percentage of participants	62.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window >0 to 38 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on CRP was defined as CRP level of <5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=80 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=116 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants	69.1 percentage of participants Interval 24.5 to	74.6 percentage of participants Interval 38.01 to	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on CRP was defined as CRP level of <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=70 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=110 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants	72.9 percentage of participants Interval 24.5 to	73.4 percentage of participants Interval 38.01 to	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window >0 to 38 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on CRP was defined as CRP level <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=97 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=87 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants	58.5 percentage of participants	77.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on CRP was defined as CRP level of <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=89 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=76 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants	60.4 percentage of participants	85.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window >0 to 38 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on FCP was defined as FCP level of <250 microgram per gram (mcg/g). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=70 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=110 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants	72.9 percentage of participants Interval 26.57 to	73.4 percentage of participants Interval 23.86 to	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=44 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=59 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants	45.7 percentage of participants Interval 26.57 to	73.4 percentage of participants Interval 23.86 to	—	—

PRIMARY outcome

Timeframe: At 14 weeks post-index (assessment time window >0 to 38 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=89 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=76 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants	60.4 percentage of participants	85.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=66 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=53 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants	59.7 percentage of participants	53.7 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Endoscopic response for CD participants was evaluated using simple endoscopic index for Crohn's disease (SES-CD) score. SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD score <=2 or based on physician assessment (for UC and CD both). SES-CD score at index date >0 relative difference was calculated (100*[Index date-52 weeks assessment]/Index date) and relative difference of >= 50% was considered response. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=16 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=28 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants	69.7 percentage of participants	65.7 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Endoscopic response in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=23 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=22 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants	44.8 percentage of participants	78.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Endoscopic remission for CD participants was evaluated using SES-CD score. The SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD score <=2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=19 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=28 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants	43.5 percentage of participants	40.5 percentage of participants	—	—

PRIMARY outcome

Timeframe: At 52 weeks post-index (assessment time window 28 to 76 weeks)

Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

Endoscopic remission in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=23 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=22 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants	35.5 percentage of participants	36.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. The PS-IPTW method was used for balancing the cohorts. Percentage of participants determined after applying this method are reported in 'Adverse events' and 'Serious adverse events' categories in this outcome measure.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Adverse Events and Serious Adverse Events Adverse event	50.7 percentage of participants	58.4 percentage of participants	33.4 percentage of participants	55.0 percentage of participants
Percentage of Participants With Adverse Events and Serious Adverse Events Serious adverse event	26.5 percentage of participants	23.2 percentage of participants	16.9 percentage of participants	23.9 percentage of participants

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Incidence rate was based on per 100 participants-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Incidence Rate of Adverse Events and Serious Adverse Events Adverse event	8.53 events per 100 participant-years Interval 98.6 to	9.53 events per 100 participant-years Interval 187.8 to	8.83 events per 100 participant-years Interval 112.5 to	10.64 events per 100 participant-years Interval 133.5 to
Incidence Rate of Adverse Events and Serious Adverse Events Serious adverse event	4.62 events per 100 participant-years	2.31 events per 100 participant-years	4.17 events per 100 participant-years	3.21 events per 100 participant-years

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with treatment related adverse events and related treatment serious adverse events were reported.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events Adverse events related to treatment	11.6 percentage of participants	19.6 percentage of participants	2.1 percentage of participants	8.5 percentage of participants
Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events Serious adverse events related to treatment	2.3 percentage of participants	5.5 percentage of participants	0.8 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events Adverse events related to treatment	1.15 events per 100 participant-years	2.70 events per 100 participant-years	0.23 events per 100 participant-years	1.10 events per 100 participant-years
Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events Serious adverse events related to treatment	0.29 events per 100 participant-years	0.53 events per 100 participant-years	0.09 events per 100 participant-years	0.06 events per 100 participant-years

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with infections, serious infections and malignancies were reported.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Percentage of Participants With Infections, Serious Infections and Malignancies	4.1 percentage of participants	19.8 percentage of participants	6.4 percentage of participants	17.8 percentage of participants

SECONDARY outcome

Timeframe: Index event period up to 6 months post-index treatment discontinuation

Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.

Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.

Outcome measures

Measure	Cohort 1, CD Participants: Vedolizumab n=83 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 Participants Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 Participants Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Incidence Rate of Infections, Serious Infections and Malignancies	0.48 events per 100 participant-years	1.75 events per 100 participant-years	0.75 events per 100 participant-years	2.42 events per 100 participant-years

Adverse Events

Cohort 1, CD Participants: Vedolizumab

Serious events: 23 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 2, CD Participants: Anti-TNF Alpha

Serious events: 26 serious events

Other events: 49 other events

Deaths: 0 deaths

Cohort 1, UC Participants: Vedolizumab

Serious events: 16 serious events

Other events: 18 other events

Deaths: 9 deaths

Cohort 2, UC Participants: Anti-TNF Alpha

Serious events: 21 serious events

Other events: 31 other events

Deaths: 3 deaths

Serious adverse events

Measure	Cohort 1, CD Participants: Vedolizumab n=83 participants at risk Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 participants at risk Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 participants at risk Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 participants at risk Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Infections and infestations Postoperative wound infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Respiratory tract infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Viral infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Liver disorder	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Immune system disorders Hypersensitivity	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Immune system disorders Anaphylactic reaction	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Crohn's disease	3.6% 3/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Abdominal pain	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Intestinal obstruction	3.6% 3/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Vomiting	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.0% 2/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Pancreatitis acute	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Rectal haemorrhage	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Abdominal distension	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Duodenal perforation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Inflammatory bowel disease	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Inguinal hernia	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Ileocaecal resection	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Abdominal wall operation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Cholecystectomy	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Hospitalisation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.0% 2/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Ileectomy	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Ileocolostomy	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Knee operation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Gastroenteritis	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Upper respiratory tract infection	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Appendicitis	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Pneumonia influenzal	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Skin reaction	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Cardiac disorders Atrial fibrillation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Cardiac disorders Cardiac failure	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Ileus paralytic	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Abdominal abscess	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Anal abscess	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Gastroenteritis viral	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Peritonsillar abscess	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Cardiac disorders Myocardial infarction	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Pyrexia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Condition aggravated	4.8% 4/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	3.1% 3/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Cholelithiasis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Surgery	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Eventration repair	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Immune system disorders Sarcoidosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Antinuclear antibody positive	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Clostridium difficile infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Fistulotomy	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Eye disorders Cataract	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Large intestine infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Colitis ulcerative	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.0% 2/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	4.1% 4/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Diarrhoea	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Nausea	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Cytomegalovirus colitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Angioplasty	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Debridement	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Hernia repair	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Ileostomy	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Prostatectomy	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Sigmoidectomy	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Blood and lymphatic system disorders Neutropenia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.0% 2/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Cardiac disorders Myocardial ischaemia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Biopsy colon	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Headache	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Renal and urinary disorders Haematuria	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Vascular disorders Superficial vein thrombosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).

Other adverse events

Measure	Cohort 1, CD Participants: Vedolizumab n=83 participants at risk Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, CD Participants: Anti-TNF Alpha n=127 participants at risk Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.	Cohort 1, UC Participants: Vedolizumab n=102 participants at risk Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated.	Cohort 2, UC Participants: Anti-TNF Alpha n=97 participants at risk Participants diagnosed with UC, who had initiated first or second-line treatment with other biologic treatment (anti-TNF alpha: infliximab, adalimumab, or golimumab) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated.
Gastrointestinal disorders Crohn's disease	3.6% 3/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	6.3% 8/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	4.1% 4/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Abdominal pain	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Vomiting	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Diarrhoea	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Gastroenteritis	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 2/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Arthritis	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Arthropathy	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Fistula	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Furuncle	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Psoriasis	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	3.1% 4/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Liver function test abnormal	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Liver function test increased	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Weight decreased	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Cardiac disorders Palpitations	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Bile duct stone	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Biliary colic	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Blood and lymphatic system disorders Anaemia	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Dizziness	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Pregnancy, puerperium and perinatal conditions Pregnancy	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Psychiatric disorders Depression	1.2% 1/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Colitis ulcerative	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	4.9% 5/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	7.2% 7/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Mouth ulceration	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Pancreatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Folliculitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Oral candidiasis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Bronchitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Catheter site infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Clostridium difficile infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Gastrointestinal infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Herpes zoster	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Pelvic abscess	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Pharyngotonsillitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Pyelonephritis acute	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Respiratory tract infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Salmonellosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Rash	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.6% 2/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Paradoxical psoriasis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Pyrexia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.4% 3/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Asthenia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	3.1% 4/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	3.1% 3/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Condition aggravated	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Chest pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Drug tolerance decreased	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Inflammation	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Oedema	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Polyp	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Balanoposthitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Ejaculation disorder	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Prostatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Testicular pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Hepatitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Injury, poisoning and procedural complications Limb injury	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Dystonia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Headache	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Memory impairment	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Eye disorders Visual impairment	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Metabolism and nutrition disorders Hyperferritinaemia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Psychiatric disorders Insomnia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Vascular disorders Deep vein thrombosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.79% 1/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Clostridium difficile colitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations H1n1 influenza	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Keratouveitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Influenza like illness	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Secretion discharge	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Ear and labyrinth disorders Tinnitus	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Eye disorders Eye pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Pregnancy, puerperium and perinatal conditions Delivery	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.98% 1/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Gastrointestinal disorders Frequent bowel movements	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
General disorders Mass	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Anal abscess	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Cellulitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Ear infection	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Gastroenteritis viral	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Molluscum contagiosum	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Infections and infestations Tonsillitis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Immune system disorders Hypersensitivity	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	2.1% 2/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Amnesia	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Nervous system disorders Neuropathy peripheral	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Renal and urinary disorders Nephrolithiasis	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Renal and urinary disorders Renal colic	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Surgical and medical procedures Eventration repair	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Investigations Lipids abnormal	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Metabolism and nutrition disorders Gout	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/83 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/127 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	0.00% 0/102 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).	1.0% 1/97 • Index event period up to 6 months post-index treatment discontinuation 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. The number of participants affected with non-serious adverse events and serious adverse events are reported as collected (statistically unprocessed data).

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

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