Trial Outcomes & Findings for Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease (NCT NCT03801928)

Results Overview

Recruitment status

COMPLETED

Target enrollment

118 participants

Primary outcome timeframe

Visit 1= Day 1

Results posted on

2021-03-02

Participant Flow

Participants included had inflammatory bowel disease (IBD), with a confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD): 1) those who newly initiated therapy with Inflectra as their first biologic, 2) transitioned to Inflectra from Remicade, 3) switched to Inflectra from other biologics. Total 118 participants were enrolled and assessed for eligibility. Out of 118, only 115 participants received Inflectra and were eligible to be included in the study.

Participants initiated or switched to Inflectra in a real-world setting and it was a decision made by physician irrespective of this study. Inflectra dose was per summary of product characteristics as determined by physician, for every 8 weeks. Participants were observed and evaluated prospectively at 4 study visits (visit 1= Day 1, visit 2= Day 90, visit 3= Day 180, visit 4= Day 365; all visits were from first dose of Inflectra) for approximately (approx.) 1 year after treatment with Inflectra.

Participant milestones

Participant milestones
Measure	UC: New Inflectra Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Overall Study STARTED	18	21	9	21	36	10
Overall Study COMPLETED	12	18	4	13	32	5
Overall Study NOT COMPLETED	6	3	5	8	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	UC: New Inflectra Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Overall Study Adverse Event	1	0	1	2	0	2
Overall Study Lack of Efficacy	0	0	1	0	0	0
Overall Study Lost to Follow-up	5	1	1	4	4	2
Overall Study Withdrawal by Subject	0	0	2	1	0	0
Overall Study Other	0	2	0	1	0	1

Baseline Characteristics

Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	Total n=115 Participants Total of all reporting groups
Age, Continuous	44.94 Years STANDARD_DEVIATION 17.72 • n=5 Participants	41.76 Years STANDARD_DEVIATION 12.68 • n=7 Participants	51.67 Years STANDARD_DEVIATION 16.39 • n=5 Participants	46.86 Years STANDARD_DEVIATION 17.98 • n=4 Participants	43.40 Years STANDARD_DEVIATION 17.02 • n=21 Participants	39.00 Years STANDARD_DEVIATION 14.51 • n=8 Participants	44.25 Years STANDARD_DEVIATION 16.29 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	19 Participants n=21 Participants	6 Participants n=8 Participants	59 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants	17 Participants n=21 Participants	4 Participants n=8 Participants	56 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized White or Caucasian American	16 Participants n=5 Participants	20 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants	31 Participants n=21 Participants	9 Participants n=8 Participants	100 Participants n=8 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Insurance Plan Coverage Canada Medicare	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	16 Participants n=8 Participants
Insurance Plan Coverage Health Maintenance Organization (HMO)	2 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	22 Participants n=21 Participants	2 Participants n=8 Participants	46 Participants n=8 Participants
Insurance Plan Coverage Medicare/Medicaid	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=8 Participants	25 Participants n=8 Participants
Insurance Plan Coverage Point of Service Plan (POS)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Insurance Plan Coverage Preferred Provider Organization (PPO)	9 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	26 Participants n=8 Participants
Insurance Plan Coverage Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Surgical History	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants	3 Participants n=8 Participants	24 Participants n=8 Participants
Disease Duration	5.96 Years STANDARD_DEVIATION 6.40 • n=5 Participants	8.88 Years STANDARD_DEVIATION 8.86 • n=7 Participants	10.00 Years STANDARD_DEVIATION 9.11 • n=5 Participants	5.89 Years STANDARD_DEVIATION 6.30 • n=4 Participants	10.59 Years STANDARD_DEVIATION 10.28 • n=21 Participants	7.22 Years STANDARD_DEVIATION 7.45 • n=8 Participants	8.26 Years STANDARD_DEVIATION 8.47 • n=8 Participants
Medication History	0 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	36 Participants n=21 Participants	9 Participants n=8 Participants	76 Participants n=8 Participants
Concomitant Medication Usage	18 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants	16 Participants n=21 Participants	9 Participants n=8 Participants	82 Participants n=8 Participants

PRIMARY outcome

Timeframe: Visit 1= Day 1

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=35 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Average Dose of Inflectra at Visit 1	457.28 milligram Standard Deviation 184.03	585.71 milligram Standard Deviation 305.43	579.44 milligram Standard Deviation 193.69	449.76 milligram Standard Deviation 102.33	521.83 milligram Standard Deviation 274.76	534.90 milligram Standard Deviation 171.15

PRIMARY outcome

Timeframe: Visit 2= Day 90

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=17 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=17 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=8 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=20 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=32 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=8 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Average Dose of Inflectra at Visit 2	491.66 milligram Standard Deviation 201.43	535.29 milligram Standard Deviation 259.67	662.36 milligram Standard Deviation 194.54	491.62 milligram Standard Deviation 172.95	506.97 milligram Standard Deviation 236.03	575.00 milligram Standard Deviation 210.76

PRIMARY outcome

Timeframe: Visit 3= Day 180

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=16 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=16 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=5 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=15 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=30 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=5 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Average Dose of Inflectra at Visit 3	556.34 milligram Standard Deviation 216.05	531.25 milligram Standard Deviation 270.11	647.67 milligram Standard Deviation 328.73	517.87 milligram Standard Deviation 162.06	544.40 milligram Standard Deviation 233.21	621.00 milligram Standard Deviation 230.55

PRIMARY outcome

Timeframe: Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=15 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=2 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=9 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=26 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=4 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Average Dose of Inflectra at Visit 4	409.28 milligram Standard Deviation 216.59	552.00 milligram Standard Deviation 270.43	450.00 milligram Standard Deviation 70.71	536.12 milligram Standard Deviation 216.39	553.20 milligram Standard Deviation 238.22	610.15 milligram Standard Deviation 229.08

PRIMARY outcome

Timeframe: Visit 1= Day 1

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=35 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean Number of Inflectra Infusions at Visit 1	1.56 infusions Standard Deviation 0.62	1.00 infusions Standard Deviation 0.00	1.44 infusions Standard Deviation 0.53	1.43 infusions Standard Deviation 0.51	1.11 infusions Standard Deviation 0.32	1.70 infusions Standard Deviation 0.67

PRIMARY outcome

Timeframe: Visit 2= Day 90

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=17 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=17 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=8 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=20 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=32 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=8 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean Number of Inflectra Infusions at Visit 2	2.06 infusions Standard Deviation 0.75	1.76 infusions Standard Deviation 0.44	2.38 infusions Standard Deviation 1.06	1.95 infusions Standard Deviation 0.83	1.47 infusions Standard Deviation 0.51	2.00 infusions Standard Deviation 0.53

PRIMARY outcome

Timeframe: Visit 3= Day 180

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=16 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=16 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=5 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=15 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=30 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=5 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean Number of Inflectra Infusions at Visit 3	1.56 infusions Standard Deviation 0.63	1.38 infusions Standard Deviation 0.62	2.20 infusions Standard Deviation 1.30	1.47 infusions Standard Deviation 0.83	1.40 infusions Standard Deviation 0.50	1.40 infusions Standard Deviation 0.55

PRIMARY outcome

Timeframe: Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=15 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=2 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=9 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=26 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=4 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean Number of Inflectra Infusions at Visit 4	2.56 infusions Standard Deviation 0.88	3.00 infusions Standard Deviation 0.85	2.50 infusions Standard Deviation 2.12	3.11 infusions Standard Deviation 1.36	3.08 infusions Standard Deviation 0.89	2.75 infusions Standard Deviation 1.71

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 Change at Visit 2	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-3.68 percentage of work time missed Standard Error 2.61	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 Change at Visit 3	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-2.04 percentage of work time missed Standard Error 2.36	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 Change at Visit 4	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-5.42 percentage of work time missed Standard Error 2.62	NA percentage of work time missed Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 Change at Visit 2	-23.7 percentage of impairment Standard Error 12	-13.18 percentage of impairment Standard Error 6	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	3.91 percentage of impairment Standard Error 3.91	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 Change at Visit 3	-33.85 percentage of impairment Standard Error 11.34	-13.53 percentage of impairment Standard Error 6.5	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	1.02 percentage of impairment Standard Error 4.07	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 Change at Visit 4	-39.94 percentage of impairment Standard Error 11.16	-17.76 percentage of impairment Standard Error 5.79	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-2.14 percentage of impairment Standard Error 4.1	NA percentage of impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 Change at Visit 2	-22.21 percentage of overall work impairment Standard Error 11.54	-14.39 percentage of overall work impairment Standard Error 5.88	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	2.33 percentage of overall work impairment Standard Error 4.7	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 Change at Visit 3	-30.2 percentage of overall work impairment Standard Error 10.16	-14.93 percentage of overall work impairment Standard Error 6.5	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	0.27 percentage of overall work impairment Standard Error 4.65	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 Change at Visit 4	-38.28 percentage of overall work impairment Standard Error 10.02	-18.82 percentage of overall work impairment Standard Error 5.82	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-4.8 percentage of overall work impairment Standard Error 4.52	NA percentage of overall work impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 Change at Visit 2	-35.51 percentage of daily activity impairment Standard Error 7.92	-14.66 percentage of daily activity impairment Standard Error 4.39	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-17.27 percentage of daily activity impairment Standard Error 6.05	3.75 percentage of daily activity impairment Standard Error 3.92	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 Change at Visit 3	-43.33 percentage of daily activity impairment Standard Error 7.66	-12.73 percentage of daily activity impairment Standard Error 6.14	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-14.09 percentage of daily activity impairment Standard Error 6.39	-0.86 percentage of daily activity impairment Standard Error 4.59	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 Change at Visit 4	-46.11 percentage of daily activity impairment Standard Error 8.36	-18.06 percentage of daily activity impairment Standard Error 6.26	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-27.64 percentage of daily activity impairment Standard Error 6.39	-2.84 percentage of daily activity impairment Standard Error 6.1	NA percentage of daily activity impairment Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Convenience score was calculated using formula = (\[Sum of Item 7 + Item 8\] - 2)/12\*100. Convenience score ranged from 0 (no convenience) to 100 (best level of convenience). Higher convenience scores indicated more convenience with medication and greater satisfaction.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 Change at Visit 2	7.08 units on a scale Standard Error 4.14	-0.16 units on a scale Standard Error 4.12	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	0.75 units on a scale Standard Error 2.77	0.57 units on a scale Standard Error 2.91	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 Change at Visit 3	6.77 units on a scale Standard Error 4.42	4.55 units on a scale Standard Error 5.38	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-4.01 units on a scale Standard Error 4.66	3.65 units on a scale Standard Error 3.1	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 Change at Visit 4	8.37 units on a scale Standard Error 5.87	4.53 units on a scale Standard Error 5.59	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-1.44 units on a scale Standard Error 3.95	-1.45 units on a scale Standard Error 2.97	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Effectiveness score was calculated using formula= (\[Sum of Item 1 + Item 2\] - 2)/12\*100. Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness). Higher effectiveness scores indicated medication was more effective and greater satisfaction.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 Change at Visit 2	23.33 units on a scale Standard Error 6.65	3.27 units on a scale Standard Error 4.75	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	12.55 units on a scale Standard Error 5.25	-10.73 units on a scale Standard Error 4.7	12.44 units on a scale Standard Error 9.98
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 Change at Visit 3	24.19 units on a scale Standard Error 6.88	10.27 units on a scale Standard Error 5.27	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	14.16 units on a scale Standard Error 7.54	-6.66 units on a scale Standard Error 4.48	11.98 units on a scale Standard Error 11.77
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 Change at Visit 4	28.54 units on a scale Standard Error 8.55	12.95 units on a scale Standard Error 5.14	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	24.45 units on a scale Standard Error 5.98	-4.97 units on a scale Standard Error 5.39	-5.72 units on a scale Standard Error 19.65

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Side effects score utilized items 4, 5 and 6. Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Side effects score was calculated using formula = (\[Sum of Item 4 + Item 5 + Item 6\] - 3)/12\*100, if one item is missing then: (\[Sum of two completed items from 4 to 6\] - 2\]/8\*100. Side effects score ranged from 0 (maximum side effects) to 100 (no side effects). Higher side effects scores indicated less side effects with medication and greater satisfaction.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 Change at Visit 2	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	1.23 units on a scale Standard Error 2.96	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	15.32 units on a scale Standard Error 5.12	-1.19 units on a scale Standard Error 6.23	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 Change at Visit 3	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	1.46 units on a scale Standard Error 4.25	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	13.34 units on a scale Standard Error 3.86	-0.3 units on a scale Standard Error 5.85	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 Change at Visit 4	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	-5.49 units on a scale Standard Error 4.25	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	15.15 units on a scale Standard Error 5.52	2.93 units on a scale Standard Error 5.27	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 Visit 4	0.00 hospitalization visits Standard Deviation 0.00	0.00 hospitalization visits Standard Deviation 0.00	0.00 hospitalization visits Standard Deviation 0.00	0.08 hospitalization visits Standard Deviation 0.28	0.03 hospitalization visits Standard Deviation 0.18	0.40 hospitalization visits Standard Deviation 0.89
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 Visit 1	0.17 hospitalization visits Standard Deviation 0.38	0.00 hospitalization visits Standard Deviation 0.00	0.33 hospitalization visits Standard Deviation 0.71	0.24 hospitalization visits Standard Deviation 0.54	0.00 hospitalization visits Standard Deviation 0.00	0.40 hospitalization visits Standard Deviation 0.52
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 Visit 2	0.06 hospitalization visits Standard Deviation 0.24	0.00 hospitalization visits Standard Deviation 0.00	0.00 hospitalization visits Standard Deviation 0.00	0.05 hospitalization visits Standard Deviation 0.22	0.17 hospitalization visits Standard Deviation 0.51	0.22 hospitalization visits Standard Deviation 0.67
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 Visit 3	0.00 hospitalization visits Standard Deviation 0.00	0.06 hospitalization visits Standard Deviation 0.24	0.17 hospitalization visits Standard Deviation 0.41	0.06 hospitalization visits Standard Deviation 0.25	0.00 hospitalization visits Standard Deviation 0.00	0.00 hospitalization visits Standard Deviation 0.00

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 Visit 2	0.06 emergency department visits Standard Deviation 0.24	0.05 emergency department visits Standard Deviation 0.23	0.25 emergency department visits Standard Deviation 0.71	0.35 emergency department visits Standard Deviation 1.35	0.11 emergency department visits Standard Deviation 0.40	0.00 emergency department visits Standard Deviation 0.00
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 Visit 3	0.06 emergency department visits Standard Deviation 0.24	0.00 emergency department visits Standard Deviation 0.00	0.00 emergency department visits Standard Deviation 0.00	0.06 emergency department visits Standard Deviation 0.25	0.03 emergency department visits Standard Deviation 0.17	0.00 emergency department visits Standard Deviation 0.00
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 Visit 4	0.00 emergency department visits Standard Deviation 0.00	0.00 emergency department visits Standard Deviation 0.00	0.00 emergency department visits Standard Deviation 0.00	0.00 emergency department visits Standard Deviation 0.00	0.09 emergency department visits Standard Deviation 0.53	0.80 emergency department visits Standard Deviation 1.10
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 Visit 1	0.22 emergency department visits Standard Deviation 0.43	0.10 emergency department visits Standard Deviation 0.44	0.11 emergency department visits Standard Deviation 0.33	0.14 emergency department visits Standard Deviation 0.36	0.03 emergency department visits Standard Deviation 0.17	0.20 emergency department visits Standard Deviation 0.42

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1	2.06 outpatient visits Standard Deviation 5.34	1.10 outpatient visits Standard Deviation 1.95	4.22 outpatient visits Standard Deviation 7.51	1.05 outpatient visits Standard Deviation 1.56	0.78 outpatient visits Standard Deviation 1.55	1.80 outpatient visits Standard Deviation 3.49
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 Visit 2	1.41 outpatient visits Standard Deviation 1.33	1.37 outpatient visits Standard Deviation 1.42	1.38 outpatient visits Standard Deviation 1.30	1.60 outpatient visits Standard Deviation 1.54	1.33 outpatient visits Standard Deviation 1.39	1.44 outpatient visits Standard Deviation 1.13
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 Visit 3	1.18 outpatient visits Standard Deviation 1.33	0.61 outpatient visits Standard Deviation 0.98	2.50 outpatient visits Standard Deviation 3.21	1.56 outpatient visits Standard Deviation 1.15	0.97 outpatient visits Standard Deviation 1.54	1.00 outpatient visits Standard Deviation 0.89
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 Visit 4	1.08 outpatient visits Standard Deviation 1.16	1.33 outpatient visits Standard Deviation 1.33	3.00 outpatient visits Standard Deviation 1.41	1.31 outpatient visits Standard Deviation 1.18	1.47 outpatient visits Standard Deviation 1.50	3.40 outpatient visits Standard Deviation 3.91

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1	0.94 GE outpatient visits Standard Deviation 1.76	0.48 GE outpatient visits Standard Deviation 0.60	2.67 GE outpatient visits Standard Deviation 4.03	0.90 GE outpatient visits Standard Deviation 1.45	0.28 GE outpatient visits Standard Deviation 0.74	1.00 GE outpatient visits Standard Deviation 1.63
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 2	0.76 GE outpatient visits Standard Deviation 0.75	0.42 GE outpatient visits Standard Deviation 0.51	0.50 GE outpatient visits Standard Deviation 0.76	0.70 GE outpatient visits Standard Deviation 0.73	0.47 GE outpatient visits Standard Deviation 0.70	1.11 GE outpatient visits Standard Deviation 0.78
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 3	0.59 GE outpatient visits Standard Deviation 0.62	0.22 GE outpatient visits Standard Deviation 0.43	0.67 GE outpatient visits Standard Deviation 1.21	1.00 GE outpatient visits Standard Deviation 0.97	0.36 GE outpatient visits Standard Deviation 0.68	0.67 GE outpatient visits Standard Deviation 0.52
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 4	0.58 GE outpatient visits Standard Deviation 0.79	0.61 GE outpatient visits Standard Deviation 0.70	0.75 GE outpatient visits Standard Deviation 0.50	0.62 GE outpatient visits Standard Deviation 0.65	0.72 GE outpatient visits Standard Deviation 0.89	1.20 GE outpatient visits Standard Deviation 0.84

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1	0.33 GP outpatient visits Standard Deviation 0.84	0.33 GP outpatient visits Standard Deviation 0.80	1.33 GP outpatient visits Standard Deviation 3.64	0.05 GP outpatient visits Standard Deviation 0.22	0.22 GP outpatient visits Standard Deviation 0.54	0.10 GP outpatient visits Standard Deviation 0.32
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 2	0.41 GP outpatient visits Standard Deviation 0.51	0.63 GP outpatient visits Standard Deviation 0.76	0.50 GP outpatient visits Standard Deviation 0.76	0.65 GP outpatient visits Standard Deviation 0.93	0.64 GP outpatient visits Standard Deviation 0.96	0.22 GP outpatient visits Standard Deviation 0.44
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 3	0.29 GP outpatient visits Standard Deviation 0.47	0.17 GP outpatient visits Standard Deviation 0.38	1.00 GP outpatient visits Standard Deviation 1.26	0.25 GP outpatient visits Standard Deviation 0.45	0.33 GP outpatient visits Standard Deviation 0.59	0.33 GP outpatient visits Standard Deviation 0.52
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 4	0.42 GP outpatient visits Standard Deviation 0.67	0.56 GP outpatient visits Standard Deviation 0.86	1.50 GP outpatient visits Standard Deviation 1.29	0.46 GP outpatient visits Standard Deviation 0.78	0.38 GP outpatient visits Standard Deviation 0.75	1.40 GP outpatient visits Standard Deviation 2.07

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (\<) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 Visit 1	13 Participants	28 Participants	7 Participants	—	—	—
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 Visit 3	12 Participants	24 Participants	3 Participants	—	—	—
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 Visit 4	11 Participants	23 Participants	3 Participants	—	—	—
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 Visit 2	16 Participants	23 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of \<3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having \>=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 Visit 1	1 Participants	15 Participants	1 Participants	—	—	—
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 Visit 2	14 Participants	16 Participants	4 Participants	—	—	—
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 Visit 3	12 Participants	14 Participants	3 Participants	—	—	—
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 Visit 4	10 Participants	16 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of \>=3 points from baseline. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 Visit 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 Visit 2	4 Participants	3 Participants	3 Participants	—	—	—
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 Visit 3	5 Participants	4 Participants	2 Participants	—	—	—
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 Visit 4	4 Participants	2 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of \>=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having \>=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 Visit 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 Visit 2	12 Participants	2 Participants	4 Participants	—	—	—
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 Visit 3	13 Participants	2 Participants	3 Participants	—	—	—
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 Visit 4	8 Participants	2 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 Change at Visit 2	17.52 units on a scale Standard Error 3.13	4.96 units on a scale Standard Error 2.2	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	6.73 units on a scale Standard Error 2.34	-0.19 units on a scale Standard Error 1.19	12.72 units on a scale Standard Error 6.19
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 Change at Visit 3	21.23 units on a scale Standard Error 3.48	6.4 units on a scale Standard Error 1.97	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	7.71 units on a scale Standard Error 2.88	0.46 units on a scale Standard Error 1.22	11.97 units on a scale Standard Error 5.41
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 Change at Visit 4	23.57 units on a scale Standard Error 3.9	8.29 units on a scale Standard Error 2.6	NA units on a scale Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	9.7 units on a scale Standard Error 2.62	0.86 units on a scale Standard Error 1.75	11.7 units on a scale Standard Error 1.57

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.

Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 Change at Visit 2	16.68 millimeter Standard Error 4.12	2.31 millimeter Standard Error 2.41	NA millimeter Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	6.16 millimeter Standard Error 5.97	0.67 millimeter Standard Error 2.79	6.83 millimeter Standard Error 6.52
Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 Change at Visit 3	17.93 millimeter Standard Error 4.28	6.49 millimeter Standard Error 2.23	NA millimeter Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	6.75 millimeter Standard Error 5.88	0.23 millimeter Standard Error 2.38	4.89 millimeter Standard Error 7.44
Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 Change at Visit 4	13.6 millimeter Standard Error 5.25	9.88 millimeter Standard Error 3.31	NA millimeter Standard Error NA Data could not be calculated as statistical model did not converge, hence no results available to report.	13.56 millimeter Standard Error 6.11	1.75 millimeter Standard Error 1.74	1.22 millimeter Standard Error 12.63

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra)

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.

Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis E1 Ulcerative proctitis	3 Participants	1 Participants	1 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis E2 Left-sided UC	6 Participants	3 Participants	4 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis E3 Extensive UC	8 Participants	16 Participants	4 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis Unknown	1 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra)

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.

Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal \[GI\]).

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Location: L1 Terminal ileum	7 Participants	12 Participants	3 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Location: L2 Colon	6 Participants	12 Participants	4 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Location: L3 Ileocolon	8 Participants	7 Participants	3 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Location: L4 Upper GI	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Location: Unknown	0 Participants	4 Participants	0 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Behavior: B1 Nonstricturing, nonpenetrating	11 Participants	3 Participants	6 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Behavior: B2 Stricturing	4 Participants	6 Participants	1 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Behavior: B3 Penetrating	4 Participants	0 Participants	1 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Behavior: P Perianal disease	0 Participants	2 Participants	1 Participants	—	—	—
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Behavior: Unknown	2 Participants	25 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra)

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.

PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having \>=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis	5.67 units on a scale Standard Deviation 2.25	1.38 units on a scale Standard Deviation 1.83	6.00 units on a scale Standard Deviation 2.65	—	—	—

SECONDARY outcome

Timeframe: Baseline (before initiation of Inflectra)

Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.

HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools. Higher HBI scores = greater disease activity.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease	3.95 units on a scale Standard Deviation 3.15	3.11 units on a scale Standard Deviation 3.05	3.57 units on a scale Standard Deviation 2.51	—	—	—

SECONDARY outcome

Timeframe: Visit 1 to 4 (approximately 1 year)

Population: The safety analysis set included all participants who signed an informed consent.

In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event). An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Infections All Infections	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Infections Serious Infections	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 1 to 4 (approximately 1 year)

Population: The safety analysis set included all participants who signed an informed consent.

In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Malignancy and Lymphoma Malignancy and Lymphoma (Serious Adverse Event)	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Malignancy and Lymphoma Malignancy and Lymphoma (Non-serious Adverse Event)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 1 to 4 (approximately 1 year)

Population: The safety analysis set included all participants who signed an informed consent.

In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Infusion-related Reactions Infusion-related reactions (serious adverse event)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Infusion-related Reactions Infusion-related reactions (non-serious adverse event)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 1 to 4 (approximately 1 year)

Population: The safety analysis set included all participants who signed an informed consent.

An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Any Serious Adverse Event	0 Participants	3 Participants	1 Participants	5 Participants	8 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1 to 4 (approximately 1 year)

Population: The safety analysis set included all participants who signed an informed consent. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure duration of Inflectra treatment (in months) is reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=35 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Duration of Inflectra Therapy	11.13 months Standard Deviation 3.71	10.42 months Standard Deviation 3.67	8.90 months Standard Deviation 4.40	10.37 months Standard Deviation 3.22	11.83 months Standard Deviation 2.27	9.59 months Standard Deviation 3.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure, number of participants who had any changes in dosing are reported.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants With Any Changes in Dosing Visit 1	3 Participants	5 Participants	0 Participants	1 Participants	7 Participants	1 Participants
Number of Participants With Any Changes in Dosing Visit 2	6 Participants	4 Participants	4 Participants	10 Participants	1 Participants	4 Participants
Number of Participants With Any Changes in Dosing Visit 3	5 Participants	2 Participants	2 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Any Changes in Dosing Visit 4	3 Participants	2 Participants	1 Participants	6 Participants	4 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Population: The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.

In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.

Outcome measures

Outcome measures
Measure	UC: New Inflectra n=18 Participants Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 Participants Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 Participants Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 Participants Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Number of Participants Who Completed Each Study Visit Visit 1	18 Participants	21 Participants	9 Participants	21 Participants	36 Participants	10 Participants
Number of Participants Who Completed Each Study Visit Visit 2	17 Participants	19 Participants	8 Participants	20 Participants	36 Participants	9 Participants
Number of Participants Who Completed Each Study Visit Visit 3	17 Participants	18 Participants	6 Participants	16 Participants	36 Participants	6 Participants
Number of Participants Who Completed Each Study Visit Visit 4	12 Participants	18 Participants	4 Participants	13 Participants	32 Participants	5 Participants

Adverse Events

UC: New Inflectra

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

UC: Inflectra After Remicade

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

UC: Inflectra After Other Biologics

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

CD: New Inflectra

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

CD: Inflectra After Remicade

Serious events: 8 serious events

Other events: 7 other events

Deaths: 0 deaths

CD: Inflectra After Other Biologics

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	UC: New Inflectra n=18 participants at risk Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 participants at risk Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 participants at risk Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 participants at risk Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 participants at risk Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 participants at risk Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Gastrointestinal disorders Abdominal abscess	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Anal fissure	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Colitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Colon stenosis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Colovesical fistula	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Crohn's disease	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	20.0% 2/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Small bowel obstruction	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Drug ineffective	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	5.6% 2/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Liver abscess	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Investigations Drug specific antibody present	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Pregnancy, puerperium and perinatal conditions Near syncope during pregnancy	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Other adverse events

Other adverse events
Measure	UC: New Inflectra n=18 participants at risk Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	UC: Inflectra After Remicade n=21 participants at risk Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	UC: Inflectra After Other Biologics n=9 participants at risk Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.	CD: New Inflectra n=21 participants at risk Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.	CD: Inflectra After Remicade n=36 participants at risk Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.	CD: Inflectra After Other Biologics n=10 participants at risk Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.
Blood and lymphatic system disorders Thrombosis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	22.2% 2/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Colitis ulcerative aggravated	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Disease recurrence	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Perianal abscess	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Drug ineffective	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Fatigue	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Infusion related reaction	5.6% 1/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Injection site bruising	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Malaise	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Hepatobiliary disorders Hepatic enzymes increased	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Immune system disorders Hypersensitivity	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Staphylococcal infection	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Osteoporosis/osteopenia	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Low-grade B cell lymphoma	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Influenza	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.8% 1/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Sinusitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	5.6% 2/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.8% 1/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	11.1% 1/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/18 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/9 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/21 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/36 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	10.0% 1/10 • Visit 1 to 4 (approximately 1 year) Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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