A Study of Guselkumab in Participants With Moderately to... | NCT04033445

NCT04033445

ID	Type	Description
CNTO1959UCO3001	Other Identifier	Janssen Research & Development, LLC
2018-004002-25	EudraCT Number
2023-504718-31-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Induction Study 1: Guselkumab Dose 1	Experimental	Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab
Induction Study 1: Guselkumab Dose 2	Experimental	Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab
Induction Study 1: Placebo IV	Placebo Comparator	Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.	Drug: Placebo
Induction Study 2: Guselkumab IV	Experimental	Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab
Induction Study 2: Placebo IV	Placebo Comparator	Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Participants will receive matching placebo IV or SC.	Induction Study 1: Placebo IV Induction Study 2: Placebo IV Maintenance Study: Placebo SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.	At Week I-12
Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.	At Week I-12
Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

Secondary Outcomes

Measure	Description	Time Frame
Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12		At Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12		At Week I-12

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Om Research LLC		Lancaster	California	93534	United States
UCLA

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42065421	Derived	Lichtenstein GR, Allegretti JR, Rubin DT, Magro F, Bressler B, Panes J, Afif W, Samaan MA, Ye BD, Yarandi S, Germinaro M, Shipitofsky N, Miao Y, Zhang H, Dignass A, Sands BE, Hisamatsu T, Peyrin-Biroulet L. Efficacy and Safety of Guselkumab for Ulcerative Colitis Through Week 92 of the QUASAR Long-Term Extension Study. Am J Gastroenterol. 2026 May 1. doi: 10.14309/ajg.0000000000004041. Online ahead of print.
41871904

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matching to guselkumab) intravenous (IV) infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 12, 2022	Sep 18, 2024

Arm/Group Information

ID	Title	Description
BG000	IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matching to guselkumab) intravenous (IV) infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.
BG001	IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 200 milligrams (mg) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.
BG002	IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 400 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.
BG003	IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matched to guselkumab) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.
BG004	IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 200 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00041.2± 15.05 BG00143.3± 14.28 BG00240.4± 13.84 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00141 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

FAS: all randomized participants (in IS-1) with a modified Mayo score of 5 to 9 who received at least 1 (partial or complete) dose of study intervention.

Posted

Number

Percentage of participants

At Week I-12

ID	Title	Description
OG000	IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matching to guselkumab) intravenous (IV) infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.
OG001	IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 200 milligrams (mg) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.
OG002	IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 400 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.

Units	Counts
Participants	OG000105 OG001101 OG002107

Title

Denominators

Categories

Title	Measurements
	OG00027.6 OG00161.4 OG00260.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel (CMH) chi-square		< 0.001		Adjusted treatment difference	33.6			2-Sided	95	20.9	46.3			Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.		Superiority
OG000 OG002		CMH chi-square test

Primary

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

Full analysis set included all randomized participants (in IS-2) with a modified Mayo score of 5 to 9 who received at least 1 (partial or complete) dose of study intervention.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week I-12

ID	Title	Description
OG000	IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matched to guselkumab) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.
OG001	IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8

Primary

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

Randomized full analysis set included all participants with a modified Mayo score of 5 to 9 who were randomized and received at least 1 (partial or complete) dose of study intervention in the maintenance study.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week M-44

ID	Title	Description
OG000	MS: Randomized: Placebo SC Every 4 Weeks (q4w)	Participants who achieved clinical response at IS-1 or IS-2 Week I-12 (Period 1) (previously treated with guselkumab) or at Week I-24 (Period 2) (previously treated with placebo and crossover to guselkumab at Week I-12) were randomized to receive placebo (matching to guselkumab) SC injection every 4 weeks (q4w) starting from Week M-0 till Week M-40. Participants who met criteria for loss of clinical response ( that is [i.e.], no longer satisfied the definition of clinical response) underwent single blinded dose adjustment (between Weeks M-8 and M-32) and received guselkumab 200 mg SC injection q4w from the time of dose adjustment through maintenance Week 40.

Secondary

Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Clinical Response at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4

Not Posted

Oct 2028

At Week I-4

Participants

Secondary

Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2

Not Posted

Oct 2028

At Week I-2

Participants

Secondary

Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12

Not Posted

Oct 2028

At Week I-12

Participants

Secondary

Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Clinical Response at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline

Not Posted

Oct 2028

At Week M-44

Participants

Secondary

Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44

Not Posted

Oct 2028

At Week M-44

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matching to guselkumab) intravenous (IV) infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	0	109	7	108	49	108
EG001	IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 200 milligrams (mg) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	0	108	1	108	33	108
EG002	IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 400 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	0	111	3	111	38	111
EG003	IS-1: Period 2: Guselkumab 200 mg IV at Weeks I-12, I-16 and I-20	Participants who initially received placebo and did not achieve clinical response at IS-1 Period 1 Week I-12 were crossed over to guselkumab and received single dose of guselkumab 200 mg IV infusion and placebo (matching to guselkumab) subcutaneous (SC) injection at Weeks I-12, I-16 and I-20. At Week I-24, participants were re-evaluated for clinical response. Participants who achieved clinical response at Week I-24 entered the maintenance study. Participants who did not achieve clinical response at Week I-24 received no further study drug and had a safety follow-up up to 12 weeks after their last dose of study drug.	0	67	2	67	17	67
EG004	IS-1: Period 2: Guselkumab 200 mg SC at Weeks I-12, I-16 and I-20	Participants who initially received guselkumab 200 mg or 400 mg IV infusion and did not achieve clinical response at IS-1 Period 1 Week I-12 received single dose of guselkumab 200 mg SC injection and placebo (matching to guselkumab) IV infusion at Weeks I-12, I-16 and I-20. At Week I-24, participants were re-evaluated for clinical response. Participants who achieved clinical response at Week I-24 entered the maintenance study. Participants who did not achieve clinical response at Week I-24 received no further study drug and had a safety follow-up up to 12 weeks after their last dose of study drug.	0	79	3	79	15	79
EG005	IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Participants received single dose of placebo (matched to guselkumab) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.	2	296	21	295	88	295
EG006	IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Participants received single dose of guselkumab 200 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.	1	440	13	440	118	440
EG007	IS-2: Period 2: Guselkumab 200 mg IV at Weeks I-12, I-16 and I-20	Participants who initially received placebo and did not achieve clinical response at Week I-12 were crossed over to guselkumab and received guselkumab 200 mg IV infusion and placebo (matching to guselkumab) SC injection at Weeks I-12, I-16 and I-20. At Week I-24, participants were re-evaluated for clinical response. Participants who achieved clinical response at Week I-24 entered the maintenance study. Participants who did not achieve clinical response at Week I-24 received no further study drug and had a safety follow-up up to 12 weeks after their last dose of study drug.	0	172	4	171	38	171
EG008	IS-2: Period 2: Guselkumab 200 mg SC at Weeks I-12, I-16 and I-20	Participants who initially received guselkumab 200 mg IV infusion and did not achieve clinical response at Week I-12 received guselkumab 200 mg SC injection and placebo (matching to guselkumab) IV infusion at Weeks I-12, I-16 and I-20. At Week I-24, participants were re-evaluated for clinical response. Participants who achieved clinical response at Week I-24 entered the maintenance study. Participants who did not achieve clinical response at Week I-24 received no further study drug and had a safety follow-up up to 12 weeks after their last dose of study drug.	0	129	3	129	37	129
EG009	MS: Randomized: Placebo SC Every 4 Weeks (q4w)	Participants who achieved clinical response at IS-1 or IS-2 Week I-12 (Period 1) (previously treated with guselkumab) or at Week I-24 (Period 2) (previously treated with placebo and crossover to guselkumab at Week I-12) were randomized to receive placebo (matching to guselkumab) SC injection every 4 weeks (q4w) starting from Week M-0 till Week M-40.	0	203	3	203	112	203
EG010	MS: Randomized: Guselkumab 100 mg SC q8w	Participants who achieved clinical response at IS-1 or IS-2 Week I-12 (Period 1) (previously treated with guselkumab) or at Week I-24 (Period 2) (previously treated with placebo and crossover to guselkumab at Week I-12) were randomized to receive guselkumab 100 mg SC injection q8w starting from Week M-4 till Week M-36.	0	197	5	197	93	197
EG011	MS: Randomized: Guselkumab 200 mg SC q4w	Participants who achieved clinical response at IS-1or IS-2 Week I-12 (Period 1)(previously treated with guselkumab) or at Week I-24 (Period 2) (previously treated with placebo and crossover to guselkumab at Week I-12) were randomized to receive guselkumab 200 mg SC injection q4w starting from Week M-0 till Week M-40.	0	199	12	199	109	199
EG012	MS: Nonrandomized: Placebo SC q4w	Participants who were treated previously with placebo (matched to guselkumab) and achieved clinical response at IS-1 or IS-2 Week I-12 (Period 1) entered in MS and received placebo (matched to guselkumab) SC injection q4w starting from Week M-0 till Week M-40.	0	122	13	122	69	122
EG013	MS: Nonrandomized: Guselkumab 200 mg SC q4w	Participants who were randomized to guselkumab and did not achieve clinical response at IS-1 or IS-2 Week I-12 (period 1) but achieved clinical response at IS-1 or IS-2 Week I-24 (Period 2) entered in MS and received guselkumab 200 mg SC injection q4w starting from Week M-0 till Week M-40.	0	125	7	125	76	125
EG014	MS: Dose Adjustment: Placebo SC q4w to Guselkumab 200 mg SC q4w	Participants who achieved clinical response in IS-1 or IS-2 (at Week I-12 or Week I-24) and randomized in MS to receive placebo (matched to guselkumab) SC injection and met criteria for loss of clinical response (i.e., no longer satisfied the definition of clinical response) underwent single blinded dose adjustment (between Weeks M-8 and M-32) and received guselkumab 200 mg SC injection q4w from the time of dose adjustment through maintenance Week 40.	0	75	2	75	28	75
EG015	MS: Dose Adjustment: Guselkumab 100 mg SC q8w to Guselkumab 200 mg SC q4w	Participants who achieved clinical response in IS-1 or IS-2 (at Week I-12 or Week I-24) and randomized in MS to receive guselkumab 100 mg SC injection q4w and met criteria for loss of clinical response (i.e., no longer satisfied the definition of clinical response) underwent single blinded dose adjustment (between Weeks M-8 and M-32) and received guselkumab 200 mg SC injection q4w from the time of dose adjustment through maintenance Week 40.	0	23	1	23	14	23
EG016	MS: Dose Adjustment: Guselkumab 200 mg SC q4w to Guselkumab 200 mg SC q4w	Participants who achieved clinical response in IS-1 or IS-2 (at Week I-12 or Week I-24) and randomized in MS to receive guselkumab 200 mg SC injection q4w and met criteria for loss of clinical response (i.e., no longer satisfied the definition of clinical response) underwent single blinded dose adjustment (between Weeks M-8 and M-32) and received guselkumab 200 mg SC injection q4w (sham dose adjustment) from the time of dose adjustment through maintenance Week 40.	0	31	2	31	20	31

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected108 at risk EG0021 affected111 at risk EG0030 affected67 at risk EG0041 affected79 at risk EG0051 affected295 at risk EG0061 affected440 at risk EG0070 affected171 at risk EG0080 affected129 at risk EG0090 affected203 at risk EG0100 affected197 at risk EG0110 affected199 at risk EG0120 affected122 at risk EG0130 affected125 at risk EG0141 affected75 at risk EG0150 affected23 at risk EG0160 affected31 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Cardiac Arrest	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pericarditis	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Cataract	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Acute Abdomen	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Anal Fistula	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Colitis Ulcerative	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Inflammatory Bowel Disease	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Intestinal Perforation	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Mucosal Prolapse Syndrome	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Umbilical Hernia	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Death	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Abscess	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Adenovirus Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Anal Abscess	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Bacterial Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Clostridium Difficile Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Complicated Appendicitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Cytomegalovirus Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Diverticulitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Herpes Zoster	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pelvic Inflammatory Disease	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Rotavirus Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Incarcerated Incisional Hernia	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Postoperative Respiratory Failure	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Clear Cell Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Fibroadenoma of Breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Guillain-Barre Syndrome	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Acute Psychosis	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Depression	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Calculus Urinary	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Labia Enlarged	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Vaginal Polyp	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Hypertensive Emergency	Vascular disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG00011 affected108 at risk EG0018 affected108 at risk EG0029 affected111 at risk EG0034 affected67 at risk EG0042 affected79 at risk EG00520 affected295 at risk EG00622 affected440 at risk EG0074 affected171 at risk EG0086 affected129 at risk EG0095 affected203 at risk EG0105 affected197 at risk EG0116 affected199 at risk EG0125 affected122 at risk EG0136 affected125 at risk EG0143 affected75 at risk EG0152 affected23 at risk EG0160 affected31 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected108 at risk EG0011 affected108 at risk EG0022 affected111 at risk EG003
Motion Sickness	Ear and labyrinth disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected108 at risk EG0014 affected108 at risk EG0023 affected111 at risk EG003
Colitis Ulcerative	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected108 at risk EG0011 affected108 at risk EG0023 affected111 at risk EG003
Colon Dysplasia	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0014 affected108 at risk EG0021 affected111 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0022 affected111 at risk EG003
Haemorrhoids Thrombosed	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Fatigue	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected108 at risk EG0011 affected108 at risk EG0020 affected111 at risk EG003
Injection Site Erythema	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Injection Site Hypersensitivity	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Injection Site Induration	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Injection Site Reaction	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected108 at risk EG0012 affected108 at risk EG0021 affected111 at risk EG003
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Acute Sinusitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected108 at risk EG0021 affected111 at risk EG003
Candida Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected108 at risk EG0016 affected108 at risk EG0022 affected111 at risk EG003
Herpes Virus Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Influenza	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Laryngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Tinea Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Tonsillitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected108 at risk EG0021 affected111 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Viral Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
White Blood Cell Count Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected108 at risk EG0020 affected111 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Iron Deficiency	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected108 at risk EG0012 affected108 at risk EG0024 affected111 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected108 at risk EG0011 affected108 at risk EG0020 affected111 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Headache	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0008 affected108 at risk EG0013 affected108 at risk EG0026 affected111 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Ejaculation Disorder	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected108 at risk EG0021 affected111 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0021 affected111 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected108 at risk EG0013 affected108 at risk EG0021 affected111 at risk EG003
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003
Phlebitis	Vascular disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected108 at risk EG0020 affected111 at risk EG003

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases