Trial Outcomes & Findings for A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006) (NCT NCT05013905)
NCT ID: NCT05013905
Last Updated: 2026-07-22
Results Overview
Number of participants who experienced treatment-emergent adverse events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to approximately 18 weeks
Results posted on
2026-07-22
Participant Flow
Eligible participants were allocated to the open-label 12-week Induction Period to receive tulisokibart by intravenous infusion. Eligible participants who completed the Induction Period and responded to tulisokibart treatment may have continued into an optional 170-week Open-label Extension (OLE) Period. Participants who entered the OLE Period were randomized to receive tulisokibart at either 100 mg every 4 weeks (q4w) or 250 mg q4w.
Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
Participant milestones
| Measure |
Induction Tulisokibart
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
OLE Tulisokibart 100 mg
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion q4w. At the discretion of the investigator, participants may have titrated up to 250 mg Q4W if disease activity was not adequately controlled.
|
OLE Tulisokibart 250 mg
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
|
|---|---|---|---|
|
Induction Period
STARTED
|
55
|
0
|
0
|
|
Induction Period
COMPLETED
|
49
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
6
|
0
|
0
|
|
Open-label Extension Period
STARTED
|
0
|
19
|
18
|
|
Open-label Extension Period
COMPLETED
|
0
|
9
|
2
|
|
Open-label Extension Period
NOT COMPLETED
|
0
|
10
|
16
|
Reasons for withdrawal
| Measure |
Induction Tulisokibart
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
OLE Tulisokibart 100 mg
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion q4w. At the discretion of the investigator, participants may have titrated up to 250 mg Q4W if disease activity was not adequately controlled.
|
OLE Tulisokibart 250 mg
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
|
|---|---|---|---|
|
Induction Period
Lost to Follow-up
|
2
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
4
|
0
|
0
|
|
Open-label Extension Period
Adverse Event
|
0
|
0
|
1
|
|
Open-label Extension Period
Physician Decision
|
0
|
1
|
0
|
|
Open-label Extension Period
Lost to Follow-up
|
0
|
0
|
1
|
|
Open-label Extension Period
Withdrawal by Subject
|
0
|
3
|
4
|
|
Open-label Extension Period
Transitioned to a separate long-term extension study
|
0
|
5
|
10
|
|
Open-label Extension Period
Relocated away from the study site
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
Baseline characteristics by cohort
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Age, Customized
Age (years) · 18-44 years
|
37 Participants
n=9 Participants
|
|
Age, Customized
Age (years) · 45-64 years
|
13 Participants
n=9 Participants
|
|
Age, Customized
Age (years) · 65+ years
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
|
Weight
|
77.6 kg
STANDARD_DEVIATION 20.6 • n=9 Participants
|
|
Duration of Disease (years)
|
10.29 years
STANDARD_DEVIATION 9.27 • n=9 Participants
|
|
Baseline Crohn's disease activity index (CDAI) Score
|
317.9 score
STANDARD_DEVIATION 67.2 • n=9 Participants
|
|
Number of Prior Exposure to Biologic Therapy
Biologic Naive
|
16 Participants
n=9 Participants
|
|
Number of Prior Exposure to Biologic Therapy
1 Prior Biologic
|
10 Participants
n=9 Participants
|
|
Number of Prior Exposure to Biologic Therapy
2 Prior Biologics
|
10 Participants
n=9 Participants
|
|
Number of Prior Exposure to Biologic Therapy
>=3 Prior Biologics
|
19 Participants
n=9 Participants
|
|
Baseline Simple Endoscopic Score for Crohn's Disease (SES-CD)
|
13.4 score
STANDARD_DEVIATION 6.7 • n=9 Participants
|
|
Concomitant Immunomodulator Use
|
8 Participants
n=9 Participants
|
|
Concomitant Oral Corticosteroid Use
|
22 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 18 weeksPopulation: All participants who received at least 1 dose of tulisokibart.
Number of participants who experienced treatment-emergent adverse events (AEs)
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Adverse Events
|
44 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 18 weeksPopulation: All participants who received at least 1 dose of tulisokibart.
Number of participants who experienced serious adverse events (SAEs)
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Serious Adverse Events
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All participants who received at least 1 dose of tulisokibart.
Number of participants who experienced AEs leading to discontinuation
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Adverse Events Leading to Discontinuation
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores with no important protocol deviations.
Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] ≥ 50% from Baseline)
Outcome measures
| Measure |
Induction Tulisokibart
n=50 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Endoscopic Improvement
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores.
Number of participants achieving clinical remission, as defined by Crohn's disease activity index \[CDAI\] score \< 150
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Clinical Remission
|
27 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores.
Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI\<150
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Endoscopic and Clinical Improvement
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores with at least one elevated biomarker at Baseline.
Biomarker and clinical composite improvement is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI\<150 in subjects with at least one elevated biomarker at baseline.
Outcome measures
| Measure |
Induction Tulisokibart
n=49 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Number of Participants Achieving Biomarker and Clinical Composite Improvement
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores who have elevated hsCRP values at Baseline.
Number of participants with normalization of hsCRP (as defined by hsCRP \< 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12
Outcome measures
| Measure |
Induction Tulisokibart
n=36 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Normalization of C-reactive Protein
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores with elevated fecal calprotectin at Baseline.
Number of participants with normalization of fecal calprotectin (fecal calprotectin \< 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12
Outcome measures
| Measure |
Induction Tulisokibart
n=44 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Normalization of Fecal Calprotectin
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores.
Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI\<150.
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Clinical Response
|
37 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All subjects who have been treated with tulisokibart with Baseline CDAI and SES-CD scores.
Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12.
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Two Component Patient-reported Outcome (PRO-2) Remission
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores, who have SES-CD scores at Baseline and Week 12.
Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Induction Tulisokibart
n=51 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
|
-2.6 score on a scale
Standard Deviation 4.32
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who were treated with tulisokibart with Baseline CDAI and SES-CD scores, and had blood samples drawn for serum concentration of tulisokibart.
Blood samples were obtained for PK analysis of the serum concentration of tulisokibart at week 12.
Outcome measures
| Measure |
Induction Tulisokibart
n=53 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Serum Concentration of Tulisokibart
|
88199.1 ng/mL
Standard Deviation 43811.21
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All participants who were treated with tulisokibart with Baseline CDAI and SES-CD scores and had blood samples collected for ADA determination
Blood samples were collected for the determination of anti-tulisokibart antibodies based on confirmatory assay. The number of participants with confirmed positive anti-tulisokibart antibodies results at any visit during the study is presented.
Outcome measures
| Measure |
Induction Tulisokibart
n=55 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Number of Participants Positive for Anti-drug Antibody (ADA)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All participants who were treated with tulisokibart with Baseline CDAI and SES-CD scores and who were ADA positive post-baseline
Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented.
Outcome measures
| Measure |
Induction Tulisokibart
n=8 Participants
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
|---|---|
|
Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
|
8 Participants
|
Adverse Events
Induction Tulisokibart
Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths
Induction Tulisokibart → OLE Tulisokibart 100 mg
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Induction Tulisokibart → OLE Tulisokibart 250 mg
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Tulisokibart
n=55 participants at risk
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
Induction Tulisokibart → OLE Tulisokibart 100 mg
n=19 participants at risk
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion q4w.
|
Induction Tulisokibart → OLE Tulisokibart 250 mg
n=18 participants at risk
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
2/55 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Crohn's disease
|
7.3%
4/55 • Number of events 5 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
15.8%
3/19 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Anal abscess
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Renal and urinary disorders
Renal colic
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
Other adverse events
| Measure |
Induction Tulisokibart
n=55 participants at risk
During the 12-week Induction Period, participants received tulisokibart administered by IV infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Safety (adverse event) analyses are reported based on the 12-week Induction Period and include protocol pre-specified safety monitoring beyond the Induction Period. Per protocol, efficacy analyses are reported based on the 12-week Induction Period.
|
Induction Tulisokibart → OLE Tulisokibart 100 mg
n=19 participants at risk
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion q4w.
|
Induction Tulisokibart → OLE Tulisokibart 250 mg
n=18 participants at risk
After completing the 12-week Induction Period, eligible participants had the option to enter the OLE Period for up to 170 weeks. Participants were randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
4/55 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.8%
1/55 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Crohn's disease
|
5.5%
3/55 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
36.8%
7/19 • Number of events 10 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
33.3%
6/18 • Number of events 8 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
16.7%
3/18 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
5.5%
3/55 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
General disorders
Infusion site pain
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
General disorders
Vaccination site pain
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Anal abscess
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
12.7%
7/55 • Number of events 7 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
15.8%
3/19 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Cystitis
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
22.2%
4/18 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Influenza
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
3/55 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Otitis media
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Sinusitis
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Tonsillitis
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
2/55 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
26.3%
5/19 • Number of events 5 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
16.7%
3/18 • Number of events 6 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
5/55 • Number of events 5 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
15.8%
3/19 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
16.7%
3/18 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Investigations
Faecal calprotectin increased
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Investigations
Weight decreased
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Headache
|
3.6%
2/55 • Number of events 3 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
15.8%
3/19 • Number of events 4 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
11.1%
2/18 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Migraine
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Product Issues
Device deposit issue
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Psychiatric disorders
Anxiety
|
3.6%
2/55 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
10.5%
2/19 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Psychiatric disorders
Depression
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Psychiatric disorders
Sleep disorder
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/55 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
2/55 • Number of events 2 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.3%
1/19 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/18 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/55 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
0.00%
0/19 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
5.6%
1/18 • Number of events 1 • Up to approximately 43 months (duration over which AEs were assessed at the participant level)
AE assessment occurred at every scheduled visit. An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. All-Cause Mortality is reported for all participants. Serious AEs and Other AEs are reported for all participants who received at least 1 dose of tulisokibart. Data are reported by treatment received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed manuscripts regarding this trial prior to submission for publication. The publication of study data may not be performed without the written prior approval of the Sponsor, and this approval shall not be unreasonably withheld.
- Publication restrictions are in place
Restriction type: OTHER