Trial Outcomes & Findings for Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade (NCT NCT02605642)

NCT ID: NCT02605642

Last Updated: 2020-01-13

Results Overview

Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.

• Recruitment status: COMPLETED
• Target enrollment: 351 participants
• Primary outcome timeframe: During the observation period of 2 years
• Results posted on: 2020-01-13

Participant Flow

351 participants were included in this study, however, 17 participants were excluded from all analysis (they were neither BDMARD naive nor switched from Remicade). They switched to CT-P13 from a BDMARD other than Remicade, therefore not considered for any analysis.

Participant milestones

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Overall Study STARTED	227	107
Overall Study Safety Set	221	107
Overall Study COMPLETED	131	86
Overall Study NOT COMPLETED	96	21

Reasons for withdrawal

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Overall Study Other	11	1
Overall Study Participant non-compliance	2	4
Overall Study Physician Decision	10	0
Overall Study Lost to Follow-up	12	1
Overall Study Adverse Event	14	2
Overall Study Withdrawal by Subject	23	2
Overall Study Lack of response	24	11

Baseline Characteristics

Number analyzed signifies participants evaluable for this baseline measure.

Baseline characteristics by cohort

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.	Total n=328 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 13.54 • n=221 Participants	52.5 years STANDARD_DEVIATION 12.61 • n=107 Participants	53.1 years STANDARD_DEVIATION 13.23 • n=328 Participants
Sex: Female, Male Female	118 Participants n=221 Participants	48 Participants n=107 Participants	166 Participants n=328 Participants
Sex: Female, Male Male	103 Participants n=221 Participants	59 Participants n=107 Participants	162 Participants n=328 Participants
Race/Ethnicity, Customized White	212 Participants n=221 Participants	106 Participants n=107 Participants	318 Participants n=328 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=221 Participants	0 Participants n=107 Participants	2 Participants n=328 Participants
Race/Ethnicity, Customized Asian	6 Participants n=221 Participants	0 Participants n=107 Participants	6 Participants n=328 Participants
Race/Ethnicity, Customized Other	1 Participants n=221 Participants	1 Participants n=107 Participants	2 Participants n=328 Participants
Height	168.44 centimeter STANDARD_DEVIATION 9.467 • n=220 Participants • Number analyzed signifies participants evaluable for this baseline measure.	173.19 centimeter STANDARD_DEVIATION 10.592 • n=106 Participants • Number analyzed signifies participants evaluable for this baseline measure.	169.98 centimeter STANDARD_DEVIATION 10.080 • n=326 Participants • Number analyzed signifies participants evaluable for this baseline measure.
Body Weight	80.80 kilograms STANDARD_DEVIATION 16.613 • n=221 Participants	83.21 kilograms STANDARD_DEVIATION 19.442 • n=107 Participants	81.59 kilograms STANDARD_DEVIATION 17.592 • n=328 Participants
Body Mass Index	28.51 kilogram per meter square STANDARD_DEVIATION 5.521 • n=220 Participants • Number analyzed signifies participants evaluable for this baseline measure.	27.74 kilogram per meter square STANDARD_DEVIATION 5.968 • n=106 Participants • Number analyzed signifies participants evaluable for this baseline measure.	28.26 kilogram per meter square STANDARD_DEVIATION 5.672 • n=326 Participants • Number analyzed signifies participants evaluable for this baseline measure.
Participants with Medical History	221 Participants n=221 Participants	107 Participants n=107 Participants	328 Participants n=328 Participants
Surgery Status Yes	20 Participants n=221 Participants	12 Participants n=107 Participants	32 Participants n=328 Participants
Surgery Status No	201 Participants n=221 Participants	95 Participants n=107 Participants	296 Participants n=328 Participants

PRIMARY outcome

Timeframe: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	404.10 days Standard Deviation 291.33	542.30 days Standard Deviation 268.55

PRIMARY outcome

Timeframe: At Day 1 of 2 year observation period

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study Disease Type: RA	52.928 months Interval 0.03 to 563.91	189.142 months Interval 12.65 to 400.2
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study Disease Type: AS	35.039 months Interval 0.03 to 551.89	159.376 months Interval 14.65 to 418.33
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study Disease Type: PsA	33.084 months Interval 0.03 to 386.5	133.979 months Interval 18.4 to 464.07

PRIMARY outcome

Timeframe: At Day 1 of 2 year observation period

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=207 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=102 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Initial Dose of CT-P13 Infusion Administered to Participants	3.00 milligram per kilogram Interval 2.4 to 6.2	4.00 milligram per kilogram Interval 2.0 to 6.6

PRIMARY outcome

Timeframe: Baseline (Day 1) of 2 year observation period

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=207 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=102 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Number of Participants by Initial Frequency of CT-P13 Infusion Received Once every 4 weeks	3 Participants	1 Participants
Number of Participants by Initial Frequency of CT-P13 Infusion Received Once every 6 weeks	79 Participants	42 Participants
Number of Participants by Initial Frequency of CT-P13 Infusion Received Once every 8 weeks	73 Participants	44 Participants
Number of Participants by Initial Frequency of CT-P13 Infusion Received Other	52 Participants	15 Participants

PRIMARY outcome

Timeframe: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Total dose of infusion received by the participants were evaluated.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Total Dose of CT-P13 Infusion Received During Observation Period	35.00 milligram per kilogram Interval 2.4 to 90.0	46.50 milligram per kilogram Interval 3.0 to 112.2

PRIMARY outcome

Timeframe: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Number of Participants With Change in CT-P13 Infusion Dose	40 Participants	8 Participants

PRIMARY outcome

Timeframe: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) Corticosteroids	28 Participants	2 Participants
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) NSAID's	27 Participants	5 Participants
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) Immunosuppressants	48 Participants	12 Participants
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) Other	26 Participants	2 Participants
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) Missing	7 Participants	5 Participants

PRIMARY outcome

Timeframe: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) SAEs	19 Participants	10 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) TEAEs	97 Participants	29 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) TEAEs of Special Interest	24 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

DAS28 calculated from the number of tender joint count (TJC) and swollen joint count (SJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters per hour; ranged from 0 to 150), and a participant's general health assessment (GH) on a 100 millimeter (mm) visual analog scale (VAS) (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 less than or equal to (<=) 3.2 implied low, greater than (>) 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=92 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=41 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 Baseline	4.033 units on a scale Standard Deviation 1.5186	2.641 units on a scale Standard Deviation 1.1401
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 Change at Month 6	-1.269 units on a scale Standard Deviation 1.5981	0.210 units on a scale Standard Deviation 1.1452
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 Change at Month 12	-0.642 units on a scale Standard Deviation 1.1220	-0.432 units on a scale Standard Deviation 1.6097
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 Change at Month 18	-0.795 units on a scale	0.534 units on a scale Standard Deviation 0.9656

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

DAS28 calculated from the number of TJC and SJC using 28 joints count, ESR (millimeters per hour; ranged from 0 to 150), and participant's GH on a 100 mm VAS (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 <= 3.2 implied low, > 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=46 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=28 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 Baseline	3.755 units on a scale Standard Deviation 1.7767	2.351 units on a scale Standard Deviation 1.0677
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 Change at Month 6	-0.913 units on a scale Standard Deviation 1.8785	0.152 units on a scale Standard Deviation 0.2737
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 Change at Month 12	-0.006 units on a scale Standard Deviation 1.7984	0.259 units on a scale Standard Deviation 0.3916
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 Change at Month 18	-0.747 units on a scale Standard Deviation 1.2115	0.840 units on a scale Standard Deviation 0.9880
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 Change at Month 24	-0.543 units on a scale	0.313 units on a scale Standard Deviation 0.2436

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASDAI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

BASDAI is a self-reported measure of disease activity in participants with AS. Participants answered 6 questions measuring symptoms of AS (fatigue, spinal pain, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 1=none to 10=severe, where lower score indicated less disease activity. The level of AS disease activity was interpreted as low (BASDAI < 4) or high (BASDAI > 4).

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=77 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=38 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Baseline	4.63 units on a scale Standard Deviation 2.263	3.06 units on a scale Standard Deviation 2.313
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 6	-1.00 units on a scale Standard Deviation 1.911	0.01 units on a scale Standard Deviation 1.470
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 12	-0.87 units on a scale Standard Deviation 1.816	0.06 units on a scale Standard Deviation 2.304
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 18	-0.55 units on a scale Standard Deviation 2.153	-0.24 units on a scale Standard Deviation 2.015
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 24	-1.14 units on a scale Standard Deviation 2.167	-1.32 units on a scale Standard Deviation 2.875

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for ASDAS. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

ASDAS is used to assess disease activity in participants with AS. It is a score combining the assessment of overall pain (Q1), duration of morning stiffness (Q2), peripheral pain/swelling (Q3), PtGA (assessed on a sale of 0 to 10, where 0 = not active and 10=very active), and C-reactive protein (CRP) in milligrams per liter (mg/L). ASDAS total score was derived using the following formula: ASDAS=0.12*Q1+0.06*Q2+0.11*GH+0.07*Q3+0.58*ln (CRP+1). The level of AS disease activity was interpreted as inactive disease (ASDAS< 1.3), moderate disease activity (1.3 <= ASDAS < 2.1), high disease activity (2.1<= ASDAS <=3.5) and very high disease activity (ASDAS > 3.5).

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=77 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=38 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 Baseline	3.153 units on a scale Standard Deviation 1.1082	2.151 units on a scale Standard Deviation 1.0456
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 Change at Month 6	-0.875 units on a scale Standard Deviation 1.3108	-0.023 units on a scale Standard Deviation 1.1017
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 Change at Month 12	-0.379 units on a scale Standard Deviation 0.9905	-0.452 units on a scale Standard Deviation 0.8156
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 Change at Month 18	-0.603 units on a scale Standard Deviation 2.7745	-0.002 units on a scale Standard Deviation 0.3630
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 Change at Month 24	-1.154 units on a scale Standard Deviation 1.2293	-0.356 units on a scale Standard Deviation 1.7080

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASFI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

BASFI is a validated self assessment tool to determine the degree of functional limitation in participants with AS. It is comprised of 10 questions which were answered by participants using a VAS ranging from 0 (being easy) to 10 (impossible). BASFI total score was calculated as the average score of the 10 questions, and ranges from 0 (no functional impairment) to 10 (maximal impairment), higher scores indicated more impairment.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=77 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=38 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 24	-1.18 units on a scale Standard Deviation 2.379	-0.42 units on a scale Standard Deviation 3.012
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Baseline	4.17 units on a scale Standard Deviation 2.804	2.89 units on a scale Standard Deviation 2.492
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 6	-0.72 units on a scale Standard Deviation 2.107	0.20 units on a scale Standard Deviation 1.146
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 12	-1.01 units on a scale Standard Deviation 2.085	0.18 units on a scale Standard Deviation 2.228
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 Change at Month 18	-0.43 units on a scale Standard Deviation 2.194	0.23 units on a scale Standard Deviation 2.257

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of HAQ-DI. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

HAQ-DI assesses the degree of difficulty a participant had experienced in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale from 0 to 3 with 0 ="no difficulty", 1 ="some difficulty", 2 = "much difficulty", and 3 ="unable to do". Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 = "no difficulty to 3 ="unable to do". Higher score indicate more difficulty in performing daily living activities.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 Baseline	0.956 units on a scale Standard Deviation 0.7493	0.646 units on a scale Standard Deviation 0.6684
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 Change at Month 6	-0.216 units on a scale Standard Deviation 0.5906	0.026 units on a scale Standard Deviation 0.3648
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 Change at Month 12	-0.207 units on a scale Standard Deviation 0.5739	-0.043 units on a scale Standard Deviation 0.5144
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 Change at Month 18	-0.150 units on a scale Standard Deviation 0.4650	-0.021 units on a scale Standard Deviation 0.3878
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 Change at Month 24	-0.398 units on a scale Standard Deviation 0.6918	-0.153 units on a scale Standard Deviation 0.7336

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

EQ-5D-3L is a standardized, participant-administered measure of health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). EQ-5D-3L Part II uses a vertical graduated VAS to measure health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 Baseline	62.7 units on a scale Standard Deviation 23.55	70.0 units on a scale Standard Deviation 22.71
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 Change at Month 6	6.0 units on a scale Standard Deviation 25.55	0.2 units on a scale Standard Deviation 20.66
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 Change at Month 12	4.2 units on a scale Standard Deviation 21.93	1.0 units on a scale Standard Deviation 26.06
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 Change at Month 18	-0.8 units on a scale Standard Deviation 28.71	-0.0 units on a scale Standard Deviation 25.98
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 Change at Month 24	4.3 units on a scale Standard Deviation 16.28	12.4 units on a scale Standard Deviation 30.99

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of -0.074 to 1.00; higher scores indicating a better health state.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 Change at Month 12	0.106 units on a scale Standard Deviation 0.2093	-0.002 units on a scale Standard Deviation 0.1900
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 Baseline	0.627 units on a scale Standard Deviation 0.2260	0.757 units on a scale Standard Deviation 0.1906
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 Change at Month 6	0.097 units on a scale Standard Deviation 0.2309	0.004 units on a scale Standard Deviation 0.1859
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 Change at Month 18	0.102 units on a scale Standard Deviation 0.1522	-0.041 units on a scale Standard Deviation 0.1416
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 Change at Month 24	0.090 units on a scale Standard Deviation 0.1479	-0.004 units on a scale Standard Deviation 0.1735

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 12	3.988 units on a scale Standard Deviation 8.6626	0.683 units on a scale Standard Deviation 8.8907
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 18	2.325 units on a scale Standard Deviation 8.1633	0.295 units on a scale Standard Deviation 11.0411
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 24	4.238 units on a scale Standard Deviation 9.2347	1.712 units on a scale Standard Deviation 7.9035
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Baseline	37.018 units on a scale Standard Deviation 10.1214	41.865 units on a scale Standard Deviation 10.2835
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 6	2.679 units on a scale Standard Deviation 9.5359	0.638 units on a scale Standard Deviation 7.5793

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 18	1.457 units on a scale Standard Deviation 8.0383	-1.145 units on a scale Standard Deviation 9.9283
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Baseline	47.154 units on a scale Standard Deviation 10.9659	52.152 units on a scale Standard Deviation 9.8788
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 6	2.603 units on a scale Standard Deviation 8.9694	-0.412 units on a scale Standard Deviation 8.7364
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 12	1.435 units on a scale Standard Deviation 8.1599	0.119 units on a scale Standard Deviation 8.3434
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 Change at Month 24	-0.593 units on a scale Standard Deviation 9.7558	5.111 units on a scale Standard Deviation 5.0804

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, 18 and 24

Population: Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of PGA. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

PGA of disease activity was measured on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extremely active. Higher scores indicated worsening of condition.

Outcome measures

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=215 Participants BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 Participants Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 Baseline	34.9 millimeters Standard Deviation 27.80	18.4 millimeters Standard Deviation 17.27
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 Change at Month 6	-13.4 millimeters Standard Deviation 26.94	0.6 millimeters Standard Deviation 18.07
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 Change at Month 12	-19.2 millimeters Standard Deviation 23.17	-1.5 millimeters Standard Deviation 19.02
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 Change at Month 18	-12.5 millimeters Standard Deviation 20.58	2.1 millimeters Standard Deviation 11.75
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 Change at Month 24	-25.6 millimeters Standard Deviation 23.49	-3.4 millimeters Standard Deviation 12.27

Adverse Events

Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive

Serious events: 19 serious events

Other events: 88 other events

Deaths: 0 deaths

Participants Who Switched From Remicade to CT-P13

Serious events: 10 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 participants at risk BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 participants at risk Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Blood and lymphatic system disorders Anaemia	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Cardiac disorders Coronary artery stenosis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Cardiac disorders Myocardial infarction	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Eye disorders Uveitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Gastrointestinal disorders Pancreatitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Autoimmune hepatitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Gallbladder polyp	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Appendicitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Bronchitis	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Erysipelas	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Herpes zoster	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Lower respiratory tract infection	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Necrotising herpetic retinopathy	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Pilonidal cyst	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Pneumonia	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Tooth abscess	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Infusion related reaction	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Pelvic fracture	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Paraesthesia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Syncope	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Product Issues Device loosening	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Psychiatric disorders Depression	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Vascular disorders Hypertensive crisis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Vascular disorders Thrombophlebitis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.

Other adverse events

Measure	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive n=221 participants at risk BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	Participants Who Switched From Remicade to CT-P13 n=107 participants at risk Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
Cardiac disorders Cardiomyopathy	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Eye disorders Uveitis	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Gastrointestinal disorders Abdominal distension	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Gastrointestinal disorders Abdominal pain	1.4% 3/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Gastrointestinal disorders Aphthous ulcer	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Gastrointestinal disorders Dyspepsia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Asthenia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Cyst	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Drug ineffective	11.3% 25/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	5.6% 6/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Impaired healing	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Malaise	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Nodule	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Peripheral swelling	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
General disorders Pyrexia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Cholelithiasis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Gallbladder polyp	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Hypertransaminasaemia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Hepatobiliary disorders Liver disorder	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Bronchitis	1.4% 3/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Cystitis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Eye infection	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Febrile infection	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Herpes virus infection	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Herpes zoster	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Influenza	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Lower respiratory tract infection	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Nasal herpes	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Nasopharyngitis	2.7% 6/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Oral herpes	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	1.9% 2/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Periodontitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Pharyngotonsillitis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Pneumonia	1.4% 3/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Respiratory tract infection	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Sinusitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Tonsillitis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Tooth abscess	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Tooth infection	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Upper respiratory tract infection	2.7% 6/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	3.7% 4/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Urinary tract infection	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Infections and infestations Viral infection	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Epicondylitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Exposure during pregnancy	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Foot fracture	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Injury, poisoning and procedural complications Infusion related reaction	6.3% 14/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	1.9% 2/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Blood pressure increased	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Drug specific antibody	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Haemoglobin decreased	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Hepatic enzyme increased	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Liver function test increased	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Investigations Mycobacterium tuberculosis complex test positive	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Metabolism and nutrition disorders Vitamin D deficiency	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Arthralgia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Arthritis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Back pain	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Bursitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Joint swelling	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Muscular weakness	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Pain in extremity	0.90% 2/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Tendonitis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Headache	2.7% 6/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Hypoaesthesia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Intercostal neuralgia	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Paraesthesia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Somnolence	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Nervous system disorders Syncope	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Psychiatric disorders Insomnia	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Renal and urinary disorders Renal cyst	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Renal and urinary disorders Renal failure	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Skin and subcutaneous tissue disorders Psoriasis	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Skin and subcutaneous tissue disorders Rash	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Skin and subcutaneous tissue disorders Skin induration	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Surgical and medical procedures Carpal tunnel decompression	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Surgical and medical procedures Varicose vein operation	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Vascular disorders Hypertension	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Vascular disorders Hypotension	0.45% 1/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.00% 0/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Vascular disorders Peripheral coldness	0.00% 0/221 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.	0.93% 1/107 • During the observation period of 2 years Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.

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.
• Publication restrictions are in place

Restriction type: OTHER