Trial Outcomes & Findings for A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease (NCT NCT00265122)

Last Updated: 2014-02-13

Results Overview

The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of \>= 25% and \>= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

131 participants

Primary outcome timeframe

Week 8

Results posted on

2014-02-13

Participant Flow

A total of 131 participants (104 in Population 1 and 27 in Population 2) were enrolled among 42 study centers (35 centers in the US, 6 in Canada, and 1 in Belgium) to receive treatment with placebo or ustekinumab (CNTO 1275) administered subcutaeously (injected under the skin \[SC\]) or intravenously (infused in a vein \[IV\]).

Participants with moderate to severe active Crohn's Disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents were enrolled and referred to as Population 1 and those with active disease who failed to respond to infliximab were enrolled and referred to as Population 2.

Participant milestones

Participant milestones
Measure	Population 1: Placebo SC Followed by Ustekinumab SC Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 2: Ustekinumab 90 mg SC Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.	Population 2: Ustekinumab 4.5 mg/kg IV Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Intervention Period 1 (Weeks 0 to 8): STARTED	26	25	27	26	14	13
Intervention Period 1 (Weeks 0 to 8): COMPLETED	24	23	22	24	13	13
Intervention Period 1 (Weeks 0 to 8): NOT COMPLETED	2	2	5	2	1	0
Intervention Period 2 (Weeks 8 to 28): STARTED	24	23	22	24	13	13
Intervention Period 2 (Weeks 8 to 28): COMPLETED	17	22	18	20	8	12
Intervention Period 2 (Weeks 8 to 28): NOT COMPLETED	7	1	4	4	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Population 1: Placebo SC Followed by Ustekinumab SC Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 2: Ustekinumab 90 mg SC Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.	Population 2: Ustekinumab 4.5 mg/kg IV Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Intervention Period 1 (Weeks 0 to 8): Withdrawal by Subject	1	1	3	0	1	0
Intervention Period 1 (Weeks 0 to 8): Lost to Follow-up	1	0	0	1	0	0
Intervention Period 1 (Weeks 0 to 8): Other	0	1	2	1	0	0
Intervention Period 2 (Weeks 8 to 28): Withdrawal by Subject	2	1	3	1	3	0
Intervention Period 2 (Weeks 8 to 28): Lost to Follow-up	1	0	0	2	2	1
Intervention Period 2 (Weeks 8 to 28): Other	4	0	1	1	0	0

Baseline Characteristics

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=26 Participants Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=25 Participants Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV n=27 Participants Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV n=26 Participants Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 2: Ustekinumab 90 mg SC n=14 Participants Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.	Population 2: Ustekinumab 4.5 mg/kg IV n=13 Participants Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.	Total n=131 Participants Total of all reporting groups
Age, Continuous	36.7 Years STANDARD_DEVIATION 13.99 • n=5 Participants	36.5 Years STANDARD_DEVIATION 13.17 • n=7 Participants	43.5 Years STANDARD_DEVIATION 11.39 • n=5 Participants	43.1 Years STANDARD_DEVIATION 12.23 • n=4 Participants	46.9 Years STANDARD_DEVIATION 13.63 • n=21 Participants	42.7 Years STANDARD_DEVIATION 11.27 • n=10 Participants	40.0 Years STANDARD_DEVIATION 12.97 • n=115 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=10 Participants	61 Participants n=115 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=10 Participants	70 Participants n=115 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.

Outcome measures

Outcome measures
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=26 Participants Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=25 Participants Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV n=27 Participants Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV n=26 Participants Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Placebo SC and IV Combined n=53 Participants All particpants who received Placebo SC and Placebo IV	Population 1: Ustekinumab SC and IV Combined n=51 Participants All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
Number of Participants in Population 1 With a Clinical Response at Week 8	13 participants	12 participants	8 participants	13 participants	21 participants	25 participants

SECONDARY outcome

Timeframe: Week 8

Population: The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.

The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of \>= 25% and \>= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.

Outcome measures

Outcome measures
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=14 Participants Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=13 Participants Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Placebo SC and IV Combined All particpants who received Placebo SC and Placebo IV	Population 1: Ustekinumab SC and IV Combined All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
Number of Participants in Population 2 With a Clinical Response at Week 8	6 participants	7 participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 8

Population: The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.

The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score \< 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.

Outcome measures

Outcome measures
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=26 Participants Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=25 Participants Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV n=27 Participants Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV n=26 Participants Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.	Population 1: Placebo SC and IV Combined n=53 Participants All particpants who received Placebo SC and Placebo IV	Population 1: Ustekinumab SC and IV Combined n=51 Participants All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
Number of Participants in Population 1 With Clinical Remission at Week 8	6 participants	6 participants	3 participants	7 participants	9 participants	13 participants

Adverse Events

Population 1: Placebo SC Followed by Ustekinumab SC

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Population 1: Ustekinumab 90 mg SC Followed by Placebo SC

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Population 2: Ustekinumab 90 mg SC

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Population 2: Ustekinumab 4.5 mg/kg IV

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=22 participants at risk Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=25 participants at risk Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV n=19 participants at risk Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled "Ustekinumab 4.5 mg/kg IV followed by Placebo IV."	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV n=27 participants at risk Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with "Placebo IV followed by Ustekinumab 4.5 mg/kg IV" who received ustekinumab IV at Week 0 was included in the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below.	Population 2: Ustekinumab 90 mg SC n=14 participants at risk Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.	Population 2: Ustekinumab 4.5 mg/kg IV n=13 participants at risk Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Cardiac disorders Coronary artery disease	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Crohn's disease	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Gastroenteritis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Histoplasmosis disseminated	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Syncope	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Renal and urinary disorders Nephrolithiasis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Colonic stenosis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.

Other adverse events

Other adverse events
Measure	Population 1: Placebo SC Followed by Ustekinumab SC n=22 participants at risk Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below.	Population 1: Ustekinumab 90 mg SC Followed by Placebo SC n=25 participants at risk Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.	Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV n=19 participants at risk Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled "Ustekinumab 4.5 mg/kg IV followed by Placebo IV."	Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV n=27 participants at risk Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with "Placebo IV followed by Ustekinumab 4.5 mg/kg IV" who received ustekinumab IV at Week 0 was included in the "Total # at Risk by any Serious Adverse Event" and "Total # at Risk by any Other Adverse Event" listed below.	Population 2: Ustekinumab 90 mg SC n=14 participants at risk Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.	Population 2: Ustekinumab 4.5 mg/kg IV n=13 participants at risk Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Nervous system disorders Migraine	13.6% 3/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Eye disorders Eyelid oedema	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Eye disorders Glaucoma	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Eye disorders Lacrimation increased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Cervical root pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Neuralgia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Burning sensation	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Injury, poisoning and procedural complications Transmission of drug via semen	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Reproductive system and breast disorders Menorrhagia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Blood and lymphatic system disorders Anaemia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Cardiac disorders Atrial flutter	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Cardiac disorders Tachycardia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Surgical and medical procedures Tooth extraction	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Blood glucose increased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Vascular disorders Flushing	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Vascular disorders Hypertension	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Metabolism and nutrition disorders Anorexia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Eye disorders Conjunctivitis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Eye disorders Dry eye	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Vascular disorders Intermittent claudication	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Blood potassium decreased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Blood pressure decreased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Occult blood positive	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Ear and labyrinth disorders Ear pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Ear and labyrinth disorders Ear congestion	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Renal and urinary disorders Nephrolithiasis	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Nail infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Dizziness	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	10.5% 2/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Pneumonia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Tooth abscess	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Vaginal candidiasis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Headache	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	24.0% 6/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.8% 3/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	14.8% 4/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	21.4% 3/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	23.1% 3/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Nausea	22.7% 5/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	10.5% 2/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	21.4% 3/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Abdominal pain	13.6% 3/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	18.5% 5/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	14.3% 2/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Abdominal distension	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	14.3% 2/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Abdominal pain upper	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Diarrhoea	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Flatulence	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Abdominal hernia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Bowel sounds abnormal	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Intestinal fistula	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Constipation	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Dry mouth	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Faecal incontinence	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Food poisoning	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Glossitis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Haemorrhoids	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Mouth ulceration	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Spigelian hernia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Gastrointestinal disorders Crohn's disease	27.3% 6/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	16.0% 4/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	21.1% 4/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	25.9% 7/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	28.6% 4/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	30.8% 4/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Upper respiratory tract infection	27.3% 6/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	20.0% 5/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.8% 3/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	14.8% 4/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	23.1% 3/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Nasopharyngitis	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Influenza	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Gastroenteritis viral	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	10.5% 2/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	23.1% 3/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Sinusitis	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	10.5% 2/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Urinary tract infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Ear infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Viral infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Oral candidiasis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Clostridial infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Gastrointestinal infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Infections and infestations Lower respiratory tract infection	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Neuropathy peripheral	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Paraesthesia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Syncope	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Nervous system disorders Syncope vasovagal	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	20.0% 5/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.8% 3/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	14.3% 2/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Pyrexia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	16.0% 4/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	23.1% 3/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Fatigue	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Pain	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Influenza like illness	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.4% 2/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Chest discomfort	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Infusion site erythema	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Infusion site pruritus	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Chest pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Adverse drug reaction	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Chills	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Feeling cold	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Malaise	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
General disorders Vessel puncture site bruise	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	11.1% 3/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Anxiety	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Insomnia	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Depression	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Restlessness	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Disorientation	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Psychiatric disorders Stress	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	12.0% 3/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	15.4% 2/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	4.0% 1/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	3.7% 1/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.1% 1/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Alanine aminotransferase increased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	8.0% 2/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Platelet count increased	4.5% 1/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	5.3% 1/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.
Investigations Blood glucose decreased	0.00% 0/22 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/25 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/19 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/27 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	0.00% 0/14 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.	7.7% 1/13 • Week 28 The number of participants at risk for adverse events was based on actual treatment received which differs from the number of participants randomized to treatment reported in Participant flow. Adverse events following the first administration of ustekinumab are included in the table.

Additional Information

Sr. Dir. Clinical Research

Centocor Research & Development, Inc.

Phone: 1-800-457-6399

Results disclosure agreements

Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER