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Clinical Trial Results:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter study to Evaluate the Safety and Efficacy of Ustekinumab Induction and MaintenanceTherapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Summary
EudraCT number	2014-005606-38
Trial protocol	DE HU AT CZ DK NL SK BE BG PL IT
Global end of trial date	30 Nov 2021

Results information
Results version number	v1
This version publication date	16 Dec 2022
First version publication date	16 Dec 2022
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CNTO1275UCO3001

ISRCTN number

US NCT number

NCT02407236

WHO universal trial number (UTN)

Sponsor organisation name

Janssen Research & Development, LLC

Sponsor organisation address

920 US Highway 202, Raritan, NJ, United States, 08869-1420

Public contact

Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

30 Nov 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 Nov 2021

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of this study was to evaluate the efficacy and safety of ustekinumab as intravenous (IV: intothe vein) infusion in induction study in subjects with moderately to severely active Ulcerative Colitis (UC) andas subcutaneous (SC) administration in maintenance study in subjects with moderately to severely activeUlcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Jul 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 26

Country: Number of subjects enrolled

Austria: 4

Country: Number of subjects enrolled

Belgium: 39

Country: Number of subjects enrolled

Bulgaria: 21

Country: Number of subjects enrolled

Canada: 16

Country: Number of subjects enrolled

Czechia: 30

Country: Number of subjects enrolled

Germany: 45

Country: Number of subjects enrolled

Denmark: 2

Country: Number of subjects enrolled

France: 54

Country: Number of subjects enrolled

United Kingdom: 21

Country: Number of subjects enrolled

Hungary: 39

Country: Number of subjects enrolled

Israel: 6

Country: Number of subjects enrolled

Italy: 33

Country: Number of subjects enrolled

Japan: 107

Country: Number of subjects enrolled

Korea, Republic of: 26

Country: Number of subjects enrolled

Netherlands: 16

Country: Number of subjects enrolled

New Zealand: 19

Country: Number of subjects enrolled

Poland: 71

Country: Number of subjects enrolled

Romania: 24

Country: Number of subjects enrolled

Russian Federation: 74

Country: Number of subjects enrolled

Serbia: 10

Country: Number of subjects enrolled

Slovakia: 10

Country: Number of subjects enrolled

Ukraine: 89

Country: Number of subjects enrolled

United States: 179

Worldwide total number of subjects

961

EEA total number of subjects

388

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

910

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 961 subjects enrolled in the Induction study. Out of 961 subjects, 783 subjects were further enrolled in the Maintenance study, out of which 588 subjects were furthur enter the Long-term extension study.

Period 1 title

Induction Study (8 weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Induction Study(IS): Placebo Intravenous (IV)

Arm description

Subjects received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, subjects who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Subjects with clinical response at Week 16 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Placebo was administered as an IV infusion.

IS: Ustekinumab 130 milligram (mg) IV

Arm description

Subjects received single dose of ustekinumab 130 mg as IV infusion at Week 0. Subjects with clinical response at Week 8 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, subjects who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Subjects with clinical response at Week 16 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 130 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Ustekinumab 130 mg was administered as an IV infusion.

IS: Ustekinumab approximately 6mg/kg IV

Arm description

Subjects received weight-range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg <=85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Subjects with clinical response at Week 8 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, subjects who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Subjects with clinical response at Week 16 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 6 mg/kg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Ustekinumab 6 mg/kg was administered as an IV infusion.

Number of subjects in period 1	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Started	319	320	322
Completed	296	309	307
Not completed	23	11	15
Adverse event, serious fatal	-	-	1
Consent withdrawn by subject	17	9	7
Physician decision	1	1	-
Adverse event, non-fatal	3	-	1
Unspecified	2	1	5
Lack of efficacy	-	-	1

Period 2 title

Maintenance Study (44 Weeks)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Maintenance study(MS): Placebo Subcutaneous (SC)

Arm description

Subjects in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo was administered as SC infusion.

MS: Ustekinumab 90mg SC every 12 weeks (q12w)

Arm description

Subjects who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and subjects who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was administered as SC infusion every 12 weeks.

MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Arm description

Subjects who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and subjects who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was administered as SC infusion every 8 weeks.

MS: Placebo IV (IS – Responders) to Placebo SC

Arm description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized subjects).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo was administered as SC infusion (Responders who received Placebo IV during IS).

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Arm description

Subjects who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized subjects).

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was administered as SC infusion (delayed responders who received Ustekinumab during IS).

Number of subjects in period 2 ^[1]	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)	MS: Placebo IV (IS – Responders) to Placebo SC	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w
Started	175	172	176	103	157
Completed	132	148	158	76	128
Not completed	43	24	18	27	29
Adverse event, serious fatal	-	-	-	-	1
Adverse event, non-fatal	19	8	4	11	10
Unspecified	5	7	8	4	6
Lack of efficacy	19	9	6	12	12

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Out of the 912 subjects who were enrolled in Induction study, only 783 subjects entered the Maintainance study and of which 588 subjects entered the LTE study.

Period 3 title

Long-term Extension Study (176 weeks)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Long Term Extension (LTE): Placebo SC

Arm description

Subjects who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).

Arm type

Placebo

Investigational medicinal product name

Placebo SC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo was continued as SC infusion in LTE phase

LTE: Ustekinumab 90 mg SC q12w

Arm description

Subjects who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was continued as SC infusion in LTE phase for subjects who were benefited from this during MS study, every 12 weeks.

LTE: Ustekinumab 90 mg SC q8w

Arm description

Subjects who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was continued as SC infusion in LTE phase for subjects who were benefited from this during MS study, every 8 weeks.

LTE: Placebo IV (IS – Responders) to Placebo SC

Arm description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized subjects).

Arm type

Placebo

Investigational medicinal product name

Placebo SC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo was continued SC in LTE phase for subjects who were benefited from this during MS study (Responders who received Placebo IV during MS study).

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Arm description

Subjects who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized subjects).

Arm type

Experimental

Investigational medicinal product name

Ustekinumab 90 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 90 mg was administered as SC infusion (delayed responders who received Ustekinumab during MS) during LTE phase.

Number of subjects in period 3 ^[2]	Long Term Extension (LTE): Placebo SC	LTE: Ustekinumab 90 mg SC q12w	LTE: Ustekinumab 90 mg SC q8w	LTE: Placebo IV (IS – Responders) to Placebo SC	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w
Started	115	141	143	73	116
Completed	34	99	101	0	95
Not completed	81	42	42	73	21
Adverse event, non-fatal	9	17	10	11	9
Unspecified	63	19	19	55	6
Lost to follow-up	-	-	1	-	-
Lack of efficacy	9	6	12	7	6

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Out of the 912 subjects who were enrolled in Induction study, only 783 subjects entered the Maintainance study and of which 588 subjects entered the LTE study.

Baseline characteristics

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Reporting group title

Induction Study(IS): Placebo Intravenous (IV)

Reporting group description

Reporting group title

IS: Ustekinumab 130 milligram (mg) IV

Reporting group description

Reporting group title

IS: Ustekinumab approximately 6mg/kg IV

Reporting group description

Reporting group values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV	Total
Number of subjects	319	320	322	961
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	303	302	305	910
From 65-84 years	16	18	17	51
85 years and over	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	41.2 ( 13.50 )	42.2 ( 13.94 )	41.7 ( 13.67 )	-
Sex: Female, Male
Units: participants
Female	122	130	127	379
Male	197	190	195	582
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	0	0	1	1
Asian	48	46	49	143
Black or African American	3	6	0	9
Native Hawaiian or Other Pacific Islander	0	0	0	0
White	248	239	243	730
More than one race	0	0	0	0
Unknown or Not Reported	12	20	17	49
Other	8	9	12	29
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	10	7	7	24
Not Hispanic or Latino	292	295	290	877
Unknown or Not Reported	17	18	25	60
Region of enrollment
Units: Subjects
AUSTRALIA	7	8	11	26
AUSTRIA	0	2	2	4
BELGIUM	22	10	7	39
BULGARIA	8	9	4	21
CANADA	7	6	3	16
CZECH REPUBLIC	8	9	13	30
DENMARK	0	0	2	2
FRANCE	14	21	19	54
GERMANY	19	14	12	45
HUNGARY	11	12	16	39
ISRAEL	0	3	3	6
ITALY	10	11	12	33
JAPAN	34	34	39	107
NETHERLANDS	5	8	3	16
NEW ZEALAND	4	4	11	19
POLAND	25	26	20	71
ROMANIA	7	9	8	24
RUSSIAN FEDERATION	26	22	26	74
SERBIA	1	6	3	10
SLOVAKIA	4	4	2	10
SOUTH KOREA	10	10	6	26
UKRAINE	32	26	31	89
UNITED KINGDOM	5	3	13	21
UNITED STATES	60	63	56	179

End points

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Reporting group title

Induction Study(IS): Placebo Intravenous (IV)

Reporting group description

Reporting group title

IS: Ustekinumab 130 milligram (mg) IV

Reporting group description

Reporting group title

IS: Ustekinumab approximately 6mg/kg IV

Reporting group description

Reporting group title

Maintenance study(MS): Placebo Subcutaneous (SC)

Reporting group description

Reporting group title

MS: Ustekinumab 90mg SC every 12 weeks (q12w)

Reporting group description

Reporting group title

MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Reporting group description

Subjects who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and subjects who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.

Reporting group title

MS: Placebo IV (IS – Responders) to Placebo SC

Reporting group description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized subjects).

Reporting group title

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Reporting group description

Reporting group title

Long Term Extension (LTE): Placebo SC

Reporting group description

Subjects who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).

Reporting group title

LTE: Ustekinumab 90 mg SC q12w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Reporting group title

LTE: Ustekinumab 90 mg SC q8w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Reporting group title

LTE: Placebo IV (IS – Responders) to Placebo SC

Reporting group description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized subjects).

Reporting group title

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Reporting group description

Subjects who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized subjects).

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per Global Definition)

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End point title

Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per Global Definition)

End point description

As per global definition, clinical remission is defined as a Mayo score less than or equal to (<=)2 points, with no individual subscore greater than (>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used. The primary efficacy analysis set (PEAS) consisted of all subjects randomized in the induction study.

End point type

Primary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	17	50	50

Statistical Analysis 1

Comparison groups

Induction Study(IS): Placebo Intravenous (IV) v IS: Ustekinumab 130 milligram (mg) IV

Number of subjects included in analysis

639

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

10.3

Confidence interval

level

95%

sides

2-sided

lower limit

5.7

upper limit

14.9

Statistical Analysis 2

Comparison groups

Induction Study(IS): Placebo Intravenous (IV) v IS: Ustekinumab approximately 6mg/kg IV

Number of subjects included in analysis

641

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

10.2

Confidence interval

level

95%

sides

2-sided

lower limit

5.6

upper limit

14.8

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per US Definition)

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End point title

Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per US Definition)

End point description

As per US definition, clinical remission was defined as absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Primary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	20	53	61

Statistical Analysis 1

Comparison groups

Induction Study(IS): Placebo Intravenous (IV) v IS: Ustekinumab 130 milligram (mg) IV

Number of subjects included in analysis

639

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

10.3

Confidence interval

level

97.5%

sides

2-sided

lower limit

4.8

upper limit

15.8

Statistical Analysis 2

Comparison groups

Induction Study(IS): Placebo Intravenous (IV) v IS: Ustekinumab approximately 6mg/kg IV

Number of subjects included in analysis

641

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

12.7

Confidence interval

level

97.5%

sides

2-sided

lower limit

upper limit

18.4

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (As per Global Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (As per Global Definition)

End point description

As per global definition, clinical remission defined as Mayo score <=2 points with no individual subscore >1. It consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment) rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores means worsening of UC. Subjects who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Primary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	42	66	77

Statistical Analysis 2

Comparison groups

Maintenance study(MS): Placebo Subcutaneous (SC) v MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Number of subjects included in analysis

351

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

19.7

Confidence interval

level

95%

sides

2-sided

lower limit

10.3

upper limit

Statistical Analysis 1

Comparison groups

Maintenance study(MS): Placebo Subcutaneous (SC) v MS: Ustekinumab 90mg SC every 12 weeks (q12w)

Number of subjects included in analysis

347

Analysis specification

Pre-specified

Analysis type

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

14.5

Confidence interval

level

95%

sides

2-sided

lower limit

5.5

upper limit

23.6

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (as per US Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (as per US Definition)

End point description

Per US definition, clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen) and Mayo endoscopy subscore of 0 (normal/inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over 3 days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal)-3 (severe). Subjects who had prohibited change in UC medication/ ostomy/ colectomy/used rescue medication after clinical flare/discontinued study agent due to lack of therapeutic effect/due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components at Week 44 were considered not to be in clinical remission. PEAS consisted of all subjects who were in clinical response to IV UST induction and were randomized at Week 0 of the maintenance study to UST 90 mg SC q8w, UST 90 mg SC q12w, or placebo SC.

End point type

Primary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	43	68	75

Statistical Analysis 2

Comparison groups

Maintenance study(MS): Placebo Subcutaneous (SC) v MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Number of subjects included in analysis

351

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

17.9

Confidence interval

level

95%

sides

2-sided

lower limit

8.6

upper limit

27.2

Statistical Analysis 1

Comparison groups

Maintenance study(MS): Placebo Subcutaneous (SC) v MS: Ustekinumab 90mg SC every 12 weeks (q12w)

Number of subjects included in analysis

347

Analysis specification

Pre-specified

Analysis type

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted treatment difference

Point estimate

15.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

24.2

Secondary: Induction Study: Number of Subjects with Endoscopic Healing (EH) at Week 8

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End point title

Induction Study: Number of Subjects with Endoscopic Healing (EH) at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	44	84	87

No statistical analyses for this end point

Secondary: Induction Study: Number of Subjects with Clinical Response at Week 8

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End point title

Induction Study: Number of Subjects with Clinical Response at Week 8

End point description

Clinical response was defined as a decrease from induction baseline in the Mayo score by >=30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	100	164	199

No statistical analyses for this end point

Secondary: Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

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End point title

Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

End point description

IBDQ is 32-item questionnaire used to evaluate disease-specific health-related quality of life. Each item score ranged from 1 (worst response) to 7 (best response). and were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. These domains scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function) and higher score means better quality of life. Total score is sum of each item score and ranges from 32\-224 with higher score means better quality of life. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing IBDQ score at Week 8 had their last value carried forward. PEAS consisted of all subjects randomized in induction study. Here, N (number of subjects analyzed) signifies those subjects who were analyzed for this endpoint.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Units on a scale
arithmetic mean (standard deviation)	16.1 ( 31.39 )	33.4 ( 32.53 )	35.0 ( 31.86 )

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Response up to Week 44

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End point title

Maintenance Study: Number of Subjects with Clinical Response up to Week 44

End point description

Clinical response: decrease from induction baseline in Mayo score by >= 30% and >= 3 points, with either decrease from induction baseline in rectal bleeding subscore >=1 or rectal bleeding subscore of 0 or 1. It includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Higher scores indicate worsening of disease. Subjects who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	78	117	125

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44

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End point title

Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44

End point description

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Subjects who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	50	75	90

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per Global Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per Global Definition)

End point description

Per global definition, clinical remission was defined as Mayo score <=2 points, with no individual subscore >1. It consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Higher scores indicate worsening of disease. Subjects who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Subjects who had missing value in corticosteroid use at Week 44 had their last value carried forward. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	41	65	74

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per US Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per US Definition)

End point description

US definition of clinical remission: absolute stool number <=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease). Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Subjects with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Subjects with missing value in corticosteroid use at Week 44 had last value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomised at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	42	67	72

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Participants who Achieved Clinical Remission at Maintenance Study Baseline (As per Global Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Participants who Achieved Clinical Remission at Maintenance Study Baseline (As per Global Definition)

End point description

Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. It includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, PGA), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range: 0 to 12, where 3 to 5= mild, 6 to 10= moderate, and 11 to 12= severe; higher scores means worsening of disease. Subjects who had prohibited change in UC medication/ostomy/colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 subscores missing at Week 44 were considered not to be in clinical remission. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects who were in clinical remission at maintenance baseline.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	45	40	38
Units: Subjects	17	26	22

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Subjects who Achieved Clinical Remission at Maintenance Study Baseline (As per US Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Subjects who Achieved Clinical Remission at Maintenance Study Baseline (As per US Definition)

End point description

US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Subjects with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects who were in clinical remission at MS baseline.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	48	52	44
Units: Subjects	16	32	27

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Mucosal Healing at Week 8

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End point title

Induction Study - Number of Subjects with Mucosal Healing at Week 8

End point description

Mucosal healing is defined as having both EH and histologic healing (HH). EH: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease ([erythema, decreased vascular pattern, mild friability]). Histologic healing: neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Subjects who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. PEAS consisted of all subjects randomised in the IS, with subjects whose mucosal healing status was determined at Week 8.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	316	316	315
Units: Subjects	64	28	58

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects in Clinical Remission with a Rectal Bleeding Subscore of 0 at Week 8 (As per Global Definition)

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End point title

Induction Study - Number of Subjects in Clinical Remission with a Rectal Bleeding Subscore of 0 at Week 8 (As per Global Definition)

End point description

As per global definition, clinical remission is defined as Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	17	49	49

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects in Symptomatic Remission at Week 8

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End point title

Induction Study - Number of Subjects in Symptomatic Remission at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	72	132	144

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects in with Normal or Inactive Mucosal Disease at Week 8

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End point title

Induction Study - Number of Subjects in with Normal or Inactive Mucosal Disease at Week 8

End point description

Normal or inactive mucosal disease is defined as an endoscopy score of 0. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	12	33	25

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in Mayo score at Week 8

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End point title

Induction Study - Change from Baseline in Mayo score at Week 8

End point description

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies those subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Units on a scale
arithmetic mean (standard deviation)	-1.8 ( 2.40 )	-3.2 ( 2.81 )	-3.5 ( 2.67 )

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in Partial Mayo Score Through Week 8

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End point title

Induction Study - Change from Baseline in Partial Mayo Score Through Week 8

End point description

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician’s global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Subjects with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies those subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	321
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 2	-1.0 ( 1.63 )	-1.5 ( 1.74 )	-1.6 ( 1.69 )
Change at Week 4	-1.4 ( 1.86 )	-2.1 ( 1.86 )	-2.5 ( 1.93 )
Change at Week 8	-1.5 ( 2.07 )	-2.6 ( 2.31 )	-2.9 ( 2.20 )

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Stool Frequency) up to Week 8

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End point title

Induction Study - Number of Subjects with individual Mayo Subscore (Stool Frequency) up to Week 8

End point description

The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies those subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	321
Units: Subjects
Week 2:Normal number of stools	16	32	26
Week 2:1-2 stools more than normal	82	99	94
Week 2: 3-4 stools more than normal	85	88	90
Week 2: 5 or more stools more than normal	136	101	111
Week 4:Normal number of stools	30	36	50
Week 4:1-2 stools more than normal	85	122	126
Week 4: 3-4 stools more than normal	81	78	72
Week 4: 5 or more stools more than normal	123	84	73
Week 8:Normal number of stools	28	66	71
Week 8:1-2 stools more than normal	93	112	110
Week 8: 3-4 stools more than normal	76	61	85
Week 8: 5 or more stools more than normal	122	81	55

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 8

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End point title

Induction Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 8

End point description

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Week 2: No blood seen	83	104	120
Week 2:Streaks of blood with stool < half time	119	122	131
Week 2: Obvious blood with stool most of the time	94	83	63
Week 2: Blood alone passed	23	11	8
Week 4:No blood seen	117	138	161
Week 4:Streaks of blood with stool < half time	103	117	115
Week 4: Obvious blood with stool most of time	75	54	40
Week 4: Blood alone passed	24	11	6
Week 8:No blood seen	119	173	204
Week 8:Streaks of blood with stool < half the time	106	85	81
Week 8: Obvious blood with stool most of the time	73	54	31
Week 8: Blood alone passed	21	8	6

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 8

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End point title

Induction Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 8

End point description

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Week 8: Normal or inactive disease	12	33	25
Week 8:Mild disease	32	51	62
Week 8: Moderate disease	99	96	84
Week 8: Severe disease	176	140	151

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Individual Mayo Subscore (Physician's Global Assessment) up to Week 8

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End point title

Induction Study - Number of Subjects with Individual Mayo Subscore (Physician's Global Assessment) up to Week 8

End point description

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician’s global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing Mayo physician’s global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Week 2: Normal	3	4	10
Week 2:Mild disease	66	82	81
Week 2: Moderate disease	194	193	181
Week 2: Severe disease	56	41	50
Week 4:Normal	13	14	22
Week 4:Mild disease	82	118	137
Week 4: Moderate disease	181	164	138
Week 4: Severe disease	43	24	25
Week 8:Normal	21	37	49
Week 8:Mild disease	83	136	135
Week 8: Moderate disease	153	115	106
Week 8: Severe disease	62	32	32

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per Global Definition)

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End point title

Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per Global Definition)

End point description

Global definition of clinical remission: Mayo score<=2 points, with no individual subscore >1. It included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, PGA), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: subjects received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Subjects with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. PEAS included all subjects randomized in the IS. Here, n (number of subjects analyzed) refer subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Subjects with BF (n= 161, 164, 166)	2	19	21
Subjects without BF (n= 158, 156, 156)	15	31	29

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per US Definition)

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End point title

Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per US Definition)

End point description

US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: subjects received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Subjects with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. PEAS consisted of all subjects randomized in the induction study. Here, n (number of subjects analyzed) refer subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Subjects with BF (n= 161, 164, 166)	4	19	22
Subjects without BF (n= 158, 156, 156)	16	34	39

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Endoscopic Healing at Week 8 by Biologic Failure Status

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End point title

Induction Study - Number of Subjects with Endoscopic Healing at Week 8 by Biologic Failure Status

End point description

Number of subjects with endoscopic healing at Week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: Subjects received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Subjects with BF (n= 161,164, 166)	11	30	35
Subjects without BF (n= 158,156, 156)	33	54	52

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Clinical Response at Week 8 by Biologic Failure Status

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End point title

Induction Study - Number of Subjects with Clinical Response at Week 8 by Biologic Failure Status

End point description

Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in rectal bleeding subscore >=1/rectal bleeding subscore=0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, PGA), rated as 0 (normal) to 3 (severe). Total score=sum of 4 subscores; range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: subjects received treatment with 1/more TNF antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response/were intolerant of medication. Subjects with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. PEAS included all subjects randomized in IS. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects
Subjects with BF (n= 161,164, 166)	44	74	95
Subjects without BF (n= 158,156, 156)	56	90	104

No statistical analyses for this end point

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

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End point title

Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

End point description

Number of subjects in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	25	60	67

No statistical analyses for this end point

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

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End point title

Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

End point description

Number of subjects in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	10	35	29

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in C-reactive Protein (CRP) Concentration Through Week 8

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End point title

Induction Study - Change from Baseline in C-reactive Protein (CRP) Concentration Through Week 8

End point description

Change from baseline in CRP concentration through Week 8 was reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing CRP value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	316	315	320
Units: milligram per liter (mg/L)
median (inter-quartile range (Q1-Q3))
Change at Week 2	-0.01 (-2.79 to 1.21)	-0.75 (-4.53 to 0.00)	-0.92 (-6.24 to 0.05)
Change at Week 4	-0.18 (-3.12 to 0.71)	-1.08 (-5.86 to 0.00)	-1.94 (-7.16 to -0.06)
Change at Week 8	0.00 (-2.47 to 2.61)	-1.30 (-5.04 to 0.30)	-1.43 (-7.36 to 0.00)

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Normalized CRP (<=3 mg/L) up to Week 8 Among Subjects with Abnormal CRP (>3 mg/L) at Baseline

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End point title

Induction Study - Number of Subjects with Normalized CRP (<=3 mg/L) up to Week 8 Among Subjects with Abnormal CRP (>3 mg/L) at Baseline

End point description

Number of subjects with normalized CRP (<=3 mg/L) up to Week 8 among subjects with abnormal CRP (>3 mg/L) at baseline were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP. PEAS consisted of all subjects randomized in the induction study, with those subjects who were having abnormal CRP at baseline.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	185	185	199
Units: Subjects
Week 2	36	54	58
Week 4	41	70	75
Week 8	39	63	77

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in Fecal Lactoferrin Concentration Through Week 8

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End point title

Induction Study - Change from Baseline in Fecal Lactoferrin Concentration Through Week 8

End point description

Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	294	302	306
Units: microgram per gram (mcg/g)
median (inter-quartile range (Q1-Q3))
Change at Week 2	0.00 (-103.22 to 120.67)	-4.67 (-140.04 to 75.46)	-24.06 (-202.88 to 60.23)
Change at Week 4	0.00 (-117.67 to 133.67)	-29.26 (-203.79 to 46.29)	-69.51 (-240.62 to 24.90)
Change at Week 8	-4.71 (-149.28 to 92.90)	-43.41 (-220.99 to 29.10)	-101.46 (-301.23 to 0.00)

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Subjects with Abnormal fecal lactoferrin (>7.24 mcg/g) at Baseline

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End point title

Induction Study - Number of Subjects with Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Subjects with Abnormal fecal lactoferrin (>7.24 mcg/g) at Baseline

End point description

Number of subjects with normalized fecal lactoferrin (<=7.24 mcg/g) up to Week 8 among subjects with abnormal fecal lactoferrin (> 7.24 mcg/g) at baseline were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin. PEAS consisted of all subjects randomized in the induction study, with those subjects who had abnormal fecal lactoferrin at baseline.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	280	291	294
Units: Subjects
Week 2	16	17	15
Week 4	16	37	33
Week 8	26	50	43

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in Fecal Calprotectin Concentration Through Week 8

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End point title

Induction Study - Change from Baseline in Fecal Calprotectin Concentration Through Week 8

End point description

Change from baseline in fecal calprotectin concentration through Week 8 was reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Subjects who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	289	296	300
Units: milligram per kilogram (mg/kg)
median (inter-quartile range (Q1-Q3))
Change at Week 2	0.00 (-702.00 to 631.00)	-29.00 (-933.50 to 492.00)	-127.00 (-1029.50 to 433.50)
Change at Week 4	-2.00 (-961.00 to 894.00)	-223.00 (-1200.50 to 266.50)	-485.50 (-1536.50 to 158.50)
Change at Week 8	-59.00 (-996.00 to 751.00)	-431.50 (-1635.50 to 175.00)	-715.50 (-1913.50 to 0.00)

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Subjects with Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline

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End point title

Induction Study - Number of Subjects with Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Subjects with Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline

End point description

Number of subjects with normalized fecal calprotectin (<=250 milligram per kilogram [mg/kg) up to Week 8 among subjects with abnormal fecal calprotectin (>250 mg/kg) at baseline were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin. PEAS consisted of all randomized subjects in the induction study, with abnormal fecal calprotectin (>250 mg/kg) at baseline.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	250	264	274
Units: Subjects
Week 2	20	37	37
Week 4	25	45	47
Week 8	51	64	70

No statistical analyses for this end point

Secondary: Induction Study - Number of Subjects with a >20-point Improvement from Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

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End point title

Induction Study - Number of Subjects with a >20-point Improvement from Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

End point description

The IBDQ is 32-item questionnaire for subjects with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score means better quality of life. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement. PEAS consisted of all subjects randomized in the induction study.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Subjects	118	196	200

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in IBDQ Dimension Scores at Week 8

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End point title

Induction Study - Change from Baseline in IBDQ Dimension Scores at Week 8

End point description

IBDQ questionnaire used to evaluate disease-specific health-related quality of life (QoL), consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response), which were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. These domains were scored as 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function);and 5 to 35 (social function). Each domain, higher score means better QoL. Total score is sum of each item score; ranges:32 to 224; higher score means better QoL. Subjects who had prohibited change in concomitant UC medication/ostomy/colectomy prior to Week 8 had their baseline value carried forward from time of event onward and subjects who had missing score at designated analysis timepoint had their last value carried forward. PEAS included all subjects randomized in IS. Here, n (number of subjects analyzed) refers subjects analyzed for this OM at specified category.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	317	319	321
Units: Units on a scale
arithmetic mean (standard deviation)
Bowel: Change at Week 8 (n= 317, 319, 321)	5.9 ( 10.34 )	12.5 ( 11.27 )	12.7 ( 11.11 )
Emotional: Change at Week 8 (n= 317, 317, 321)	5.3 ( 12.33 )	10.1 ( 12.39 )	11.2 ( 12.33 )
Systemic: Change at Week 8 (n= 317, 319, 321)	2.3 ( 5.59 )	5.1 ( 5.59 )	5.2 ( 5.65 )
Social: Change at Week 8 (n= 317, 318, 321)	2.7 ( 6.55 )	5.7 ( 7.41 )	5.9 ( 6.44 )

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8

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End point title

Induction Study - Change from Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8

End point description

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Subjects who had prohibited change in concomitant UC medication/ostomy/colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing component summary score at Week 8 had their last value carried forward. PEAS included all subjects randomized in the IS. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	318	322
Units: Units on a scale
arithmetic mean (standard deviation)
PCS: Change at Week 8	2.1 ( 6.39 )	4.7 ( 6.49 )	5.2 ( 6.16 )
MCS: Change at Week 8	2.2 ( 10.20 )	5.3 ( 9.63 )	5.1 ( 9.72 )

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8

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End point title

Induction Study - Change from Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8

End point description

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Subjects who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing individual scale at a designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects who were analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	318	322
Units: Units on a scale
arithmetic mean (standard deviation)
Physical functioning: Change at Week 8	1.7 ( 6.46 )	3.0 ( 6.46 )	3.4 ( 6.51 )
Role-physical: Change at Week 8	2.4 ( 9.51 )	5.9 ( 9.34 )	6.1 ( 8.53 )
Bodily pain: Change at Week 8	2.6 ( 9.71 )	6.0 ( 9.45 )	6.8 ( 9.08 )
General health: Change at Week 8	1.5 ( 7.36 )	4.7 ( 7.74 )	4.5 ( 7.10 )
Vitality: Change at Week 8	2.7 ( 9.93 )	6.1 ( 9.35 )	6.8 ( 9.78 )
Social functioning: Change at Week 8	3.0 ( 10.52 )	6.6 ( 10.25 )	6.4 ( 9.84 )
Role-emotional: Change at Week 8	1.6 ( 11.04 )	4.4 ( 11.04 )	3.6 ( 10.53 )
Mental health: Change at Week 8	2.0 ( 9.86 )	4.7 ( 9.14 )	5.1 ( 9.27 )

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire index Score at Week 8

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End point title

Induction Study - Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire index Score at Week 8

End point description

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Subjects who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing score at a designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	317	319	322
Units: Units on a scale
arithmetic mean (standard deviation)	0.04 ( 0.182 )	0.09 ( 0.182 )	0.11 ( 0.172 )

No statistical analyses for this end point

Secondary: Induction Study - Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8

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End point title

Induction Study - Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8

End point description

The EQ-5D VAS records the subject's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual subjects. Subjects who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing score at a designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects randomized in the induction study. Here, N (number of subjects analyzed) signifies subjects analyzed for this OM.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	317	319	322
Units: Units on a scale
arithmetic mean (standard deviation)	5.71 ( 19.584 )	13.64 ( 20.394 )	13.51 ( 18.447 )

No statistical analyses for this end point

Secondary: Induction Study - Percentage of Subjects with Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8

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End point title

Induction Study - Percentage of Subjects with Change from Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8

End point description

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Subjects who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or subjects who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of subjects with various responses to the 5 dimensions were reported. PEAS consisted of all subjects randomized in the induction study. Here, n (number of subjects analyzed) signifies subjects who were analyzed for this OM at specified category.

End point type

Secondary

End point timeframe

Baseline and Week 8

End point values	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab approximately 6mg/kg IV
Number of subjects analysed	319	320	322
Units: Percentage of subjects
number (not applicable)
Mobility:Improved at Week 8 (n= 317, 319, 322)	18.0	16.3	24.2
Mobility:No change at Week 8 (n= 317, 319, 322)	71.9	71.8	66.8
Mobility:Worsened at Week 8 (n= 317, 319, 322)	10.1	11.9	9.0
Self-care:Improved at Week 8 (n= 317, 319, 322)	5.4	6.9	7.5
Self-care:No change at Week 8 (n= 317, 319, 322)	89.6	88.4	90.4
Self-care:Worsened at Week 8 (n= 317, 319, 322)	5.0	4.7	2.2
Usual activities:Improved Week 8(n=317,319,322)	34.1	49.5	45.0
Usual activities:No Change Week 8(n=317,319,322)	51.1	40.4	44.1
Usual activities:Worsened Week 8(n=317,319,322)	14.8	10.0	10.9
Pain/discomfort:Improved Week 8(n=319,320,322)	34.4	44.2	43.5
Pain/discomfort:No Change Week 8(n= 317,319,322)	49.8	48.3	48.1
Pain/discomfort:Worsened Week 8(n=317,319,322)	15.8	7.5	8.4
Anxiety/depression:Improved Week 8(n=317,319,322)	26.8	33.5	37.6
Anxiety/depression:No Change Week 8(n=317,319,322)	55.5	54.2	51.6
Anxiety/depression:Worsened Week 8(n=317,319,322)	17.7	12.2	10.9

No statistical analyses for this end point

Secondary: Maintenance Study - Change from Maintenance Baseline in Mayo score at Week 44

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End point title

Maintenance Study - Change from Maintenance Baseline in Mayo score at Week 44

End point description

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and PGA), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5=mild; 6 to 10=moderate; and 11 to 12=severe; higher scores means worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Baseline and Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Units on a scale
arithmetic mean (standard deviation)	1.6 ( 3.45 )	0.1 ( 3.02 )	-0.5 ( 2.88 )

No statistical analyses for this end point

Secondary: Maintenance Study - Change from Induction Baseline in Mayo Score at Week 44

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End point title

Maintenance Study - Change from Induction Baseline in Mayo Score at Week 44

End point description

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and PGA), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5=mild; 6 to 10=moderate; and 11 to 12=severe; higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication/ostomy/colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Induction Baseline and Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Units on a scale
arithmetic mean (standard deviation)	-3.3 ( 3.34 )	-5.0 ( 3.27 )	-5.6 ( 3.17 )

No statistical analyses for this end point

Secondary: Maintenance Study - Number of Subjects with Individual Mayo Subscore (Stool Frequency) up to Week 44

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End point title

Maintenance Study - Number of Subjects with Individual Mayo Subscore (Stool Frequency) up to Week 44

End point description

Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects
Week 4:Normal number of stools	56	61	58
Week 4:1-2 stools more than normal	91	76	86
Week 4: 3-4 stools more than normal	21	26	29
Week 4: 5 or more stools more than normal	7	9	3
Week 8:Normal number of stools	70	62	61
Week 8:1-2 stools more than normal	69	75	84
Week 8: 3-4 stools more than normal	22	25	26
Week 8: 5 or more stools more than normal	14	10	5
Week 12:Normal number of stools	62	55	64
Week 12:1-2 stools more than normal	72	75	85
Week 12: 3-4 stools more than normal	20	28	21
Week 12: 5 or more stools more than normal	21	14	6
Week 16:Normal number of stools	63	51	73
Week 16:1-2 stools more than normal	66	78	77
Week 16: 3-4 stools more than normal	25	27	15
Week 16: 5 or more stools more than normal	21	16	11
Week 20:Normal number of stools	59	63	67
Week 20:1-2 stools more than normal	55	65	85
Week 20: 3-4 stools more than normal	34	26	15
Week 20: 5 or more stools more than normal	27	18	9
Week 24:Normal number of stools	50	64	72
Week 24:1-2 stools more than normal	63	61	73
Week 24: 3-4 stools more than normal	31	31	20
Week 24: 5 or more stools more than normal	31	16	11
Week 28:Normal number of stools	52	64	67
Week 28:1-2 stools more than normal	53	64	76
Week 28: 3-4 stools more than normal	34	24	22
Week 28: 5 or more stools more than normal	36	20	11
Week 32:Normal number of stools	51	59	72
Week 32:1-2 stools more than normal	55	66	73
Week 32: 3-4 stools more than normal	35	25	18
Week 32: 5 or more stools more than normal	34	22	13
Week 36:Normal number of stools	49	59	77
Week 36:1-2 stools more than normal	52	60	66
Week 36: 3-4 stools more than normal	36	29	18
Week 36: 5 or more stools more than normal	38	24	15
Week 40:Normal number of stools	48	55	81
Week 40:1-2 stools more than normal	50	65	58
Week 40: 3-4 stools more than normal	36	26	21
Week 40: 5 or more stools more than normal	40	26	16
Week 44:Normal number of stools	46	61	71
Week 44:1-2 stools more than normal	53	57	72
Week 44: 3-4 stools more than normal	35	28	16
Week 44: 5 or more stools more than normal	41	25	17

No statistical analyses for this end point

Secondary: Maintenance Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 44

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End point title

Maintenance Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 44

End point description

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Subjects who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects
Week 4:No blood seen	149	148	143
Week 4:Streaks of blood with stool < half time	20	23	29
Week 4: Obvious blood with stool most of the time	4	1	24
Week 4: Blood alone passed	2	0	0
Week 8:No blood seen	139	151	141
Week 8:Streaks of blood with stool < half time	27	17	31
Week 8: Obvious blood with stool most of time	6	3	4
Week 8:Blood alone passed	3	1	0
Week 12:No blood seen	141	144	149
Week 12:Streaks of blood with stool <half time	21	19	18
Week 12: Obvious blood with stool most of the time	10	8	6
Week 12: Blood alone passed	3	1	3
Week 16:No blood seen	134	145	150
Week 16:Streaks of blood with stool < half time	24	17	17
Week 16: Obvious blood with stool most of the time	13	8	8
Week 16: Blood alone passed	4	2	1
Week 20:No blood seen	120	141	144
Week 20:Streaks of blood with stool <half time	31	17	20
Week 20: Obvious blood with stool most of the time	19	12	11
Week 20: Blood alone passed	5	2	1
Week 24:No blood seen	114	139	144
Week 24:Streaks of blood with stool <half time	32	18	19
Week 24: Obvious blood with stool most of the time	23	12	11
Week 24: Blood alone passed	6	3	2
Week 28:No blood seen	114	141	147
Week 28:Streaks of blood with stool <half time	26	18	12
Week 28: Obvious blood with stool most of the time	28	10	14
Week 28: Blood alone passed	7	3	3
Week 32:No blood seen	109	138	147
Week 32:Streaks of blood with stool <half time	32	16	13
Week 32: Obvious blood with stool most of the time	25	14	14
Week 32: Blood alone passed	9	4	2
Week 36:No blood seen	108	136	150
Week 36:Streaks of blood with stool <half time	30	18	9
Week 36: Obvious blood with stool most of the time	28	15	15
Week 36: Blood alone passed	9	3	2
Week 40:No blood seen	105	132	147
Week 40:Streaks of blood with stool <half time	33	22	10
Week 40: Obvious blood with stool most of the time	28	13	17
Week 40: Blood alone passed	9	5	2
Week 44:No blood seen	101	137	139
Week 44::Streaks of blood with stool <half time	35	15	16
Week 44: Obvious blood with stool most of the time	30	15	19
Week 44: Blood alone passed	9	5	2

No statistical analyses for this end point

Secondary: Maintenance Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 44

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End point title

Maintenance Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 44

End point description

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0=normal/ inactive disease, 1=mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores=worse disease. Subjects who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects
Week 44: Normal or inactive disease	33	43	52
Week 44:Mild disease	21	37	42
Week 44: Moderate disease	40	42	50
Week 44: Severe disease	81	50	32

No statistical analyses for this end point

Secondary: Maintenance Study - Number of Subjects with individual Mayo Subscore (Physician's Global Assessment) up to Week 44

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End point title

Maintenance Study - Number of Subjects with individual Mayo Subscore (Physician's Global Assessment) up to Week 44

End point description

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician’s global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects
Week 4:Normal	62	61	59
Week 4:Mild disease	100	99	105
Week 4: Moderate disease	12	12	11
Week 4: Severe disease	1	0	1
Week 8:Normal	65	70	76
Week 8:Mild disease	90	89	88
Week 8: Moderate disease	17	13	11
Week 8:Severe disease	3	0	1
Week 12:Normal	66	68	73
Week 12:Mild disease	79	81	88
Week 12: Moderate disease	26	16	14
Week 12: Severe disease	4	7	1
Week 16:Normal	67	82	83
Week 16:Mild disease	68	69	78
Week 16: Moderate disease	32	14	13
Week 16: Severe disease	8	7	2
Week 20:Normal	64	85	84
Week 20:Mild disease	57	63	73
Week 20: Moderate disease	41	16	16
Week 20: Severe disease	12	8	3
Week 24:Normal	54	84	91
Week 24:Mild disease	61	65	68
Week 24: Moderate disease	44	14	15
Week 24: Severe disease	16	9	2
Week 28:Normal	58	86	89
Week 28:Mild disease	52	63	65
Week 28: Moderate disease	47	14	20
Week 28: Severe disease	18	9	2
Week 32:Normal	55	84	92
Week 32:Mild disease	52	56	62
Week 32: Moderate disease	46	23	19
Week 32: Severe disease	22	9	3
Week 36: Normal	59	78	93
Week 36:Mild disease	45	60	60
Week 36: Moderate disease	47	24	19
Week 36: Severe disease	24	10	4
Week 40:Normal	57	83	91
Week 40:Mild disease	48	50	60
Week 40: Moderate disease	44	24	21
Week 40: Severe disease	26	15	4
Week 44:Normal	47	78	85
Week 44:Mild disease	44	54	62
Week 44:Moderate disease	57	24	25
Week 44: Severe disease	27	16	4

No statistical analyses for this end point

Secondary: Maintenance Study - Change from Maintenance Baseline in Partial Mayo Score Through Week 44

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End point title

Maintenance Study - Change from Maintenance Baseline in Partial Mayo Score Through Week 44

End point description

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and PGA subscores), rated as 0 (normal) to 3 (severe). Total score is sum of 3 subscores and values range from 0 to 9; higher scores means worse disease. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the IS carried forward from the time of the event onward. Subjects who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Baseline through Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 4	-0.2 ( 1.24 )	-0.3 ( 1.23 )	-0.1 ( 1.26 )
Change at Week 8	-0.1 ( 1.59 )	-0.3 ( 1.15 )	-0.2 ( 1.44 )
Change at Week 12	0.1 ( 1.82 )	0.0 ( 1.66 )	-0.2 ( 1.63 )
Change at Week 16	0.3 ( 2.07 )	-0.1 ( 1.76 )	-0.3 ( 1.76 )
Change at Week 20	0.6 ( 2.36 )	-0.1 ( 1.91 )	-0.2 ( 1.92 )
Change at Week 24	0.9 ( 2.34 )	0.0 ( 2.02 )	-0.3 ( 1.88 )
Change at Week 28	1.0 ( 2.53 )	-0.1 ( 1.95 )	-0.2 ( 1.94 )
Change at Week 32	1.1 ( 2.60 )	0.1 ( 2.12 )	-0.2 ( 1.96 )
Change at Week 36	1.2 ( 2.62 )	0.2 ( 2.13 )	-0.2 ( 2.08 )
Change at Week 40	1.3 ( 2.64 )	0.3 ( 2.27 )	-0.2 ( 1.97 )
Change at Week 44	1.5 ( 2.63 )	0.3 ( 2.29 )	0.0 ( 2.09 )

No statistical analyses for this end point

Secondary: Maintenance Study - Change from Induction Baseline in Partial Mayo Score Through Week 44

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End point title

Maintenance Study - Change from Induction Baseline in Partial Mayo Score Through Week 44

End point description

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and PGA subscores; rated as 0 [normal] to 3 [severe]). Total score is sum of the 3 subscores and values range from 0 to 9; higher scores means worse disease. Subjects who had a prohibited change in concomitant UC medication/ostomy/colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the IS carried forward from the time of the event onward. Subjects who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Baseline through Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 4	-4.2 ( 1.70 )	-4.5 ( 1.76 )	-4.4 ( 1.72 )
Change at Week 8	-4.1 ( 1.80 )	-4.5 ( 1.68 )	-4.5 ( 1.85 )
Change at Week 12	-3.9 ( 2.07 )	-4.2 ( 2.02 )	-4.5 ( 2.02 )
Change at Week 16	-3.7 ( 2.17 )	-4.3 ( 2.07 )	-4.6 ( 2.08 )
Change at Week 20	-3.4 ( 2.26 )	-4.3 ( 2.13 )	-4.5 ( 2.13 )
Change at Week 24	-3.1 ( 2.36 )	-4.2 ( 2.26 )	-4.5 ( 2.18 )
Change at Week 28	-3.0 ( 2.49 )	-4.3 ( 2.26 )	-4.4 ( 2.27 )
Change at Week 32	-2.9 ( 2.51 )	-4.1 ( 2.40 )	-4.5 ( 2.30 )
Change at Week 36	-2.8 ( 2.43 )	-4.0 ( 2.43 )	-4.5 ( 2.40 )
Change at Week 40	-2.7 ( 2.51 )	-3.9 ( 2.46 )	-4.5 ( 2.39 )
Change at Week 44	-2.5 ( 2.52 )	-3.9 ( 2.49 )	-4.3 ( 2.48 )

No statistical analyses for this end point

Secondary: Maintenance Study: Number of subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44

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End point title

Maintenance Study: Number of subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44

End point description

Number of subjects in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Subjects who had a prohibited change in concomitant UC medication/ostomy/colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects	49	70	84

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44

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End point title

Maintenance Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44

End point description

Number of subjects in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Subjects who had a prohibited change in concomitant UC medication/ostomy/colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	30	42	48

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects in Symptomatic Remission at Week 44

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End point title

Maintenance Study: Number of Subjects in Symptomatic Remission at Week 44

End point description

Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Subjects who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects	79	107	119

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 by Biologic Failure Status (As per Global Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission at Week 44 by Biologic Failure Status (As per Global Definition)

End point description

Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) refers subjects who were analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects
Participants with BF (n=88, 70, 91)	15	16	36
Participants without BF (n= 87, 102, 85)	27	50	41

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 by Biologic Failure Status (As per US Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission at Week 44 by Biologic Failure Status (As per US Definition)

End point description

US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: subjects received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects
Subjects with BF (n=88, 70, 91)	15	17	34
Subjects without BF (n=87, 102, 85)	28	51	41

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Response up to Week 44 by Biologic Failure Status

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End point title

Maintenance Study: Number of Subjects with Clinical Response up to Week 44 by Biologic Failure Status

End point description

Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: subjects received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects
Subjects with BF (n= 88, 70, 91)	34	39	59
Subjects without BF (87, 102, 85)	44	78	66

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44 by Biologic Failure Status

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End point title

Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44 by Biologic Failure Status

End point description

Number of subjects with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: subjects received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM with specified category.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: subjects
Subjects with BF (n=88, 70, 91)	20	18	41
Subjects without BF (n= 87, 102, 85)	30	57	49

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44 Among Subjects who had Achieved Endoscopic Healing at Maintenance Baseline

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End point title

Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44 Among Subjects who had Achieved Endoscopic Healing at Maintenance Baseline

End point description

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects who had achieved endoscopic healing at maintenance baseline.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	71	68	57
Units: subjects	25	41	37

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Normal or Inactive Mucosal Disease at Week 44

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End point title

Maintenance Study: Number of Subjects with Normal or Inactive Mucosal Disease at Week 44

End point description

Normal or inactive mucosal disease is defined as an endoscopy score of 0. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Subjects	32	41	51

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 and not Receiving Concomitant Corticosteroids at Week 44 Among Subjects who Received Concomitant Corticosteroids at Maintenance Baseline (per Global Definition)

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End point title

Maintenance Study: Number of Subjects with Clinical Remission at Week 44 and not Receiving Concomitant Corticosteroids at Week 44 Among Subjects who Received Concomitant Corticosteroids at Maintenance Baseline (per Global Definition)

End point description

Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Subjects with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. subjects missing value in corticosteroid use had their last value carried forward. PEAS consisted of all Subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, subjects who were receiving concomitant corticosteroids at maintenance baseline.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	91	82	92
Units: Subjects	17	25	36

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 and not Receiving Concomitant Corticosteroids at Week 44 Among Subjects who Received Concomitant Corticosteroids at Maintenance Baseline (per US Definition)

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End point title

End point description

US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Subjects with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects who were receiving concomitant corticosteroids at maintenance baseline.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	91	82	92
Units: subjects	18	27	34

No statistical analyses for this end point

Secondary: MS: Change from Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Subjects who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline

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End point title

MS: Change from Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Subjects who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline

End point description

The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the subjects receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. Subjects who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Subjects who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint. PEAS consisted of all subjects who were in clinical response to IV ustekinumab IS and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects who were receiving concomitant corticosteroids at maintenance baseline.

End point type

Secondary

End point timeframe

Baseline Through Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	75	69	82
Units: milligram per day (mg/day)
arithmetic mean (standard deviation)
Change at Week 4	-7.4 ( 5.73 )	-7.8 ( 5.48 )	-7.2 ( 5.42 )
Change at Week 8	-10.8 ( 6.77 )	-11.7 ( 8.17 )	-12.1 ( 6.81 )
Change at Week 12	-10.1 ( 8.7 )	-11.6 ( 9.16 )	-12.6 ( 7.00 )
Change at Week 16	-10.1 ( 7.73 )	-12.1 ( 8.37 )	-12.8 ( 6.98 )
Change at Week 20	-9.5 ( 7.85 )	-12.0 ( 8.44 )	-12.6 ( 7.27 )
Change at Week 24	-8.9 ( 7.96 )	-11.9 ( 8.62 )	-12.5 ( 7.88 )
Change at Week 28	-7.8 ( 8.72 )	-11.5 ( 9.23 )	-12.4 ( 7.56 )
Change at Week 32	-7.7 ( 8.18 )	-11.4 ( 8.98 )	-12.1 ( 8.21 )
Change at Week 36	-7.6 ( 8.28 )	-11.3 ( 8.80 )	-11.7 ( 8.34 )
Change at Week 40	-7.2 ( 8.04 )	-11.5 ( 8.62 )	-11.5 ( 8.37 )
Change at Week 44	-6.8 ( 7.98 )	-11.0 ( 8.87 )	-11.5 ( 8.37 )

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects not Receiving Concomitant Corticosteroids at Week 44 Among Subjects who Received Concomitant Corticosteroids at Maintenance Baseline

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End point title

Maintenance Study: Number of Subjects not Receiving Concomitant Corticosteroids at Week 44 Among Subjects who Received Concomitant Corticosteroids at Maintenance Baseline

End point description

Number of subjects not receiving concomitant corticosteroids at Week 44 among subjects who received concomitant corticosteroids at maintenance Baseline were reported. Subjects who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Subjects who had a missing value in corticosteroid use at Week 44 had their last value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, subjects who were receiving concomitant corticosteroids at maintenance baseline.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	91	82	92
Units: Subjects	43	56	73

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects who Maintained 20-point Improvement from Induction Baseline in IBDQ up to Week 44 Among Subjects with a >20-point Improvement in IBDQ at Maintenance Baseline

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End point title

Maintenance Study: Number of Subjects who Maintained 20-point Improvement from Induction Baseline in IBDQ up to Week 44 Among Subjects with a >20-point Improvement in IBDQ at Maintenance Baseline

End point description

IBDQ consists of 32 items questionnaire, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life UC. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects with >20-point Improvement in IBDQ at the maintenance baseline.

End point type

Secondary

End point timeframe

Up to Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	129	144	143
Units: subjects	64	95	102

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in the IBDQ Score at Week 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in the IBDQ Score at Week 20 and 44

End point description

IBDQ consists of 32 items questionnaire , each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the MS to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Week 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	173	172	174
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 20 (n= 174, 172, 174)	-7.0 ( 31.37 )	0.8 ( 29.05 )	5.5 ( 27.40 )
Change at Week 44 (n= 173, 172, 174)	-15.1 ( 35.43 )	-3.0 ( 32.89 )	3.9 ( 31.54 )

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44

End point description

IBDQ consists of 32 items questionnaire , each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. PEAS included all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM for specified categories at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Week 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	174	172	174
Units: Units on a scale
arithmetic mean (standard deviation)
Bowel:Change at Week 20 (n= 174, 172, 174)	-3.2 ( 10.88 )	-0.5 ( 9.16 )	1.3 ( 9.56 )
Bowel:Change at Week 44 (n= 173, 172, 174)	-5.7 ( 12.34 )	-1.6 ( 10.99 )	0.8 ( 10.49 )
Emotional: Change at Week 20 (n= 174, 172, 174)	-1.9 ( 12.16 )	0.9 ( 11.12 )	2.2 ( 10.56 )
Emotional: Change at Week 44 (n= 173, 172, 174)	-4.7 ( 13.84 )	-0.5 ( 12.17 )	1.4 ( 12.22 )
Systemic: Change at Week 20 (n= 174, 172, 174)	-1.1 ( 5.54 )	0.0 ( 5.31 )	0.7 ( 5.24 )
Systemic: Change at Week 44 (n= 173, 172, 174)	-2.2 ( 5.52 )	-0.5 ( 5.97 )	0.5 ( 5.83 )
Social: Change at Week 20 (n= 174, 172, 174)	-0.7 ( 5.93 )	0.3 ( 6.59 )	1.4 ( 5.44 )
Social: Change at Week 44 (n= 173, 172, 174)	-2.5 ( 6.72 )	-0.5 ( 7.10 )	1.1 ( 6.29 )

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44

End point description

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	173	172	175
Units: Units on a scale
arithmetic mean (standard deviation)
PCS: Change at Week 20	-1.2 ( 6.20 )	-0.2 ( 6.15 )	0.8 ( 5.55 )
PCS: Change at Week 44	-1.7 ( 6.45 )	-0.4 ( 7.14 )	1.3 ( 5.68 )
MCS: Change at Week 20	-1.1 ( 8.90 )	1.0 ( 8.91 )	0.4 ( 9.10 )
MCS: Change at Week 44	-2.4 ( 9.89 )	0.3 ( 8.41 )	0.3 ( 9.51 )

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44

End point description

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Subjects who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and subjects with missing individual scale score at timepoint had last available value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Units on a scale
arithmetic mean (standard deviation)
Physical functioning: Change at Week 20	-0.61 ( 6.140 )	-0.01 ( 5.506 )	0.51 ( 4.809 )
Physical functioning: Change at Week 44	-1.40 ( 5.932 )	-0.44 ( 5.624 )	0.66 ( 4.819 )
Role-physical: Change at Week 20	-0.61 ( 8.630 )	0.17 ( 7.996 )	0.23 ( 8.144 )
Role-physical: Change at Week 44	-2.27 ( 9.400 )	-0.84 ( 8.293 )	1.08 ( 8.096 )
Bodily pain:Change at Week 20	-2.80 ( 9.081 )	-0.30 ( 8.556 )	1.06 ( 8.971 )
Bodily pain:Change at Week 44	-2.33 ( 9.245 )	0.23 ( 9.340 )	0.94 ( 8.350 )
General health:Change at Week 20	-0.95 ( 7.468 )	0.67 ( 7.802 )	1.14 ( 7.133 )
General health:Change at Week 44	-1.62 ( 7.449 )	0.24 ( 8.722 )	1.92 ( 7.955 )
Vitality:Change at Week 20	-1.71 ( 8.876 )	0.74 ( 8.917 )	0.39 ( 9.209 )
Vitality:Change at Week 44	-3.18 ( 10.389 )	0.11 ( 9.152 )	0.53 ( 9.743 )
Social functioning: Change at Week 20	-0.87 ( 9.245 )	0.47 ( 8.979 )	0.72 ( 9.907 )
Social functioning: Change at Week 44	-1.83 ( 10.186 )	0.06 ( 9.515 )	1.12 ( 9.678 )
Role-emotional: Change at Week 20	-0.93 ( 9.586 )	0.47 ( 9.338 )	0.14 ( 8.637 )
Role-emotional: Change at Week 44	-2.21 ( 10.187 )	0.04 ( 9.324 )	0.10 ( 8.199 )
Mental health:Change at Week 20	-1.07 ( 9.085 )	1.08 ( 8.631 )	0.61 ( 8.467 )
Mental health:Change at Week 44	-2.15 ( 9.992 )	0.06 ( 8.042 )	0.53 ( 8.915 )

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire index Score at Weeks 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire index Score at Weeks 20 and 44

End point description

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	173	172	175
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 20	-0.036 ( 0.1535 )	-0.002 ( 0.1694 )	0.016 ( 0.1471 )
Change at Week 44	-0.048 ( 0.1587 )	0.008 ( 0.1656 )	0.025 ( 0.1674 )

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44

End point description

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual subjects. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	173	172	175
Units: Units on a scale
arithmetic mean (standard deviation)
Change at Week 20	-4.0 ( 16.70 )	-0.3 ( 17.29 )	2.6 ( 17.80 )
Change at Week 44	-7.7 ( 18.75 )	-2.2 ( 19.87 )	2.4 ( 17.28 )

No statistical analyses for this end point

Secondary: Maintenance Study: Percentage of Subjects with Change from Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44

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End point title

Maintenance Study: Percentage of Subjects with Change from Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44

End point description

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Percentage of subjects with various responses to the 5 dimensions were reported. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects who were analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 20, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	175	172	176
Units: Percentage of Subjects
number (not applicable)
Change at Week (W) 20: Mobility:Improved	12.7	10.5	13.7
Change at W 20:Mobility:No change	75.7	79.1	78.9
Change at W 20:Mobility:Worsened	11.6	10.5	7.4
Change at W 44:Mobility:Improved	9.8	11.6	12.0
Change at W 44:Mobility:No change	75.1	76.2	79.4
Change at W 44:Mobility:Worsened	15.0	12.2	8.6
Change at W 20:Self-care:Improved	1.7	1.7	4.0
Change at W 20:Self-care:No change	91.9	93.6	93.7
Change at W 20:Self-care:Worsened	6.4	4.7	2.3
Change at W 44:Self-care:Improved	1.7	2.3	4.0
Change at W 44:Self-care:No change	95.4	93.0	93.1
Change at W 44:Self-care:Worsened	2.9	4.7	2.9
Change at W 20:Usual activities:Improved	12.7	17.4	22.3
Change at W 20:Usual activities:No Change	64.2	66.9	64.0
Change at W 20:Usual activities:Worsened	23.1	15.7	13.7
Change at W 44: Usual activities:Improved	14.5	24.4	25.1
Change at W 44:Usual activities:No Change	52.6	55.2	62.9
Change at W 44:Usual activities:Worsened	32.9	20.3	12.0
Change at W 20:Pain/discomfort: Improved	16.8	22.1	23.4
Change at W 20:Pain/discomfort: No Change	54.9	58.7	58.9
Change at W 20:Pain/discomfort: Worsened	28.3	19.2	17.7
Change at W 44:Pain/discomfort: Improved	17.9	25.0	30.3
Change at W 44:Pain/discomfort: No Change	46.2	55.8	50.9
Change at W 44:Pain/discomfort: Worsened	35.8	19.2	18.9
Change at W 20:Anxiety/depression: Improved	16.2	20.3	24.6
Change at W 20:Anxiety/depression: No Change	62.4	61.6	58.3
Change at W 20:Anxiety/depression: Worsened	21.4	18.0	17.1
Change at W 44:Anxiety/depression: Improved	17.9	20.3	26.9
Change at W 44:Anxiety/depression: No Change	56.1	58.7	58.9
Change at W 44:Anxiety/depression: Worsened	26.0	20.9	14.3

No statistical analyses for this end point

Secondary: Maintenance Study: Number of Subjects with Mucosal Healing at Week 44

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End point title

Maintenance Study: Number of Subjects with Mucosal Healing at Week 44

End point description

Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with subjects whose mucosal healing status was determined at Week 44 with evaluable biopsy.

End point type

Secondary

End point timeframe

Week 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	170	170	172
Units: Subjects	41	66	79

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44

End point description

Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Subjects who had a missing CRP value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects who were analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 8, 24, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	174	170	176
Units: milligram per liter (mg/L)
median (inter-quartile range (Q1-Q3))
Change at Week 8 (n= 174, 172, 176)	0.05 (-0.67 to 0.81)	-0.03 (-0.92 to 0.37)	-0.04 (-1.50 to 0.92)
Change at Week 24 (n= 174, 172, 176)	0.68 (-0.28 to 2.34)	0.13 (-0.75 to 1.16)	-0.03 (-1.53 to 0.59)
Change at Week 44 (n= 174, 172, 175)	1.07 (0.00 to 5.18)	0.38 (-0.35 to 1.53)	-0.07 (-1.73 to 0.79)

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44

End point description

Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Subjects who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects who were analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 8, 24, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	167	161	163
Units: microgram per gram (mcg/g)
median (inter-quartile range (Q1-Q3))
Change at Week 8 (n= 167, 161, 163)	0.0 (-44.8 to 72.0)	0.0 (-35.0 to 48.5)	-1.4 (-52.0 to 30.9)
Change at Week 24 (n= 166 161, 161)	2.2 (-45.3 to 139.9)	-0.8 (-47.9 to 35.1)	-2.3 (-65.5 to 25.5)
Change at Week 44 (n= 166, 159, 160)	0.8 (-34.2 to 177.4)	-1.9 (-54.4 to 35.1)	-9.1 (-101.6 to 7.8)

No statistical analyses for this end point

Secondary: Maintenance Study: Change from Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44

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End point title

Maintenance Study: Change from Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44

End point description

Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Subjects who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Subjects who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward. PEAS consisted of all subjects who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of subjects analyzed) signifies subjects who were analyzed for this OM at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 8, 24, and 44

End point values	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	MS: Ustekinumab 90mg SC every 8 weeks (q8w)
Number of subjects analysed	168	160	161
Units: milligram per kilogram (mg/kg)
arithmetic mean (inter-quartile range (Q1-Q3))
Change at Week 8 (n= 168, 160, 161)	0.0 (-0.158 to 557.0)	-18.5 (-368.5 to 225.5)	-31.0 (-380.0 to 205.0)
Change at Week 24 (n= 165, 160, 159)	125.0 (-97.0 to 1223.0)	-31.5 (-413.5 to 385.0)	-46.0 (-530.0 to 318.0)
Change at Week 44 (n= 164, 158, 159)	229.5 (-102.5 to 1387.0)	-37.5 (-476.0 to 274.0)	-85.0 (-742.0 to 166.0)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to Week 220

Adverse event reporting additional description

The safety analysis set included subjects who received at least 1 dose of studyagent, including partial dose, according to actual treatment received.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Induction Study(IS): Placebo Intravenous (IV)

Reporting group description

Reporting group title

IS: Ustekinumab 130 milligram (mg) IV

Reporting group description

Reporting group title

IS: Ustekinumab Nonresponders at Week 8

Reporting group description

Subjects who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Subjects with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.

Reporting group title

Maintenance study(MS): Placebo Subcutaneous (SC)

Reporting group description

Reporting group title

MS: Ustekinumab 90mg SC every 12 weeks (q12w)

Reporting group description

Reporting group title

IS: Ustekinumab approximately 6mg/kg IV

Reporting group description

Subjects received weight-range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but <=85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Subjects with clinical response at Week 8 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, subjects who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Subjects with clinical response at Week 16 were eligible to enter the maintenance study. Subjects who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Reporting group title

IS: Placebo-Nonresponders at Week 8

Reporting group description

Subjects who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.

Reporting group title

MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Reporting group description

Subjects who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and subjects who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.

Reporting group title

Long Term Extension (LTE): Placebo SC

Reporting group description

Subjects who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).

Reporting group title

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Reporting group title

LTE: Ustekinumab 90 mg SC q12w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Reporting group title

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Reporting group description

Subjects who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized subjects).

Reporting group title

MS: Placebo IV (IS – Responders) to Placebo SC

Reporting group description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized subjects).

Reporting group title

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC q8w in the maintenance study and had a sham dose adjustment to ustekinumab 90 mg SC q8w during the LTE.

Reporting group title

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC q12w in the maintenance study and had a dose adjustment to ustekinumab 90 mg SC q8w during the LTE.

Reporting group title

LTE: Ustekinumab 90 mg SC q8w

Reporting group description

Subjects who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Reporting group title

LTE: Placebo IV (IS – Responders) to Placebo SC

Reporting group description

Subjects with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized subjects).

Reporting group title

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Reporting group description

Subjects who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16) received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized subjects ).

Induction Study(IS): Placebo Intravenous (IV)

IS: Ustekinumab 130 milligram (mg) IV

IS: Ustekinumab Nonresponders at Week 8

Maintenance study(MS): Placebo Subcutaneous (SC)

MS: Ustekinumab 90mg SC every 12 weeks (q12w)

IS: Ustekinumab approximately 6mg/kg IV

IS: Placebo-Nonresponders at Week 8

MS: Ustekinumab 90mg SC every 8 weeks (q8w)

Long Term Extension (LTE): Placebo SC

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

LTE: Ustekinumab 90 mg SC q12w

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

MS: Placebo IV (IS – Responders) to Placebo SC

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w

LTE: Placebo IV (IS – Responders) to Placebo SC

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Total subjects affected by serious adverse events

subjects affected / exposed

22 / 319 (6.90%)

12 / 321 (3.74%)

12 / 233 (5.15%)

17 / 175 (9.71%)

13 / 172 (7.56%)

11 / 320 (3.44%)

7 / 184 (3.80%)

15 / 176 (8.52%)

6 / 115 (5.22%)

8 / 56 (14.29%)

13 / 141 (9.22%)

11 / 157 (7.01%)

8 / 103 (7.77%)

3 / 37 (8.11%)

6 / 64 (9.38%)

15 / 143 (10.49%)

10 / 73 (13.70%)

14 / 116 (12.07%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal Cell Carcinoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

1 / 157 (0.64%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

2 / 116 (1.72%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Bowen's Disease

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Colon Adenoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Colon Cancer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colorectal Cancer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hepatic Adenoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

1 / 115 (0.87%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intraductal Papilloma of Breast

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lentigo Maligna

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ovarian Adenoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pituitary Tumour Benign

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Prostate Cancer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal Adenocarcinoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal Adenoma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal Cancer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin Papilloma

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Testis Cancer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Deep Vein Thrombosis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

2 / 320 (0.63%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Extremity Necrosis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhage

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vasculitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pregnancy, puerperium and perinatal conditions

Abortion Spontaneous

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

2 / 176 (1.14%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

0 / 1

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Non-Cardiac Chest Pain

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Anaphylactic Reaction

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Benign Prostatic Hyperplasia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Ovarian Cyst

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Prostatitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Acute Respiratory Failure

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

1 / 157 (0.64%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Bronchiectasis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperventilation

subjects affected / exposed

0 / 319 (0.00%)

2 / 321 (0.62%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pleurisy

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary Embolism

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary Eosinophilia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Confusional State

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental Status Changes

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Suicidal Ideation

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

1 / 37 (2.70%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Ankle Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bladder Injury

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Clavicle Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Fibula Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hip Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Jaw Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

1 / 37 (2.70%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lumbar Vertebral Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meniscus Injury

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Procedural Intestinal Perforation

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Radius Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

1 / 157 (0.64%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal Compression Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tibia Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Traumatic Fracture

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Congenital, familial and genetic disorders

Hydrocele

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute Myocardial Infarction

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Atrial Fibrillation

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac Arrest

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Coronary Artery Disease

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial Infarction

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pericarditis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

1 / 115 (0.87%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Aphasia

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cognitive Disorder

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epilepsy

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Generalised Tonic-Clonic Seizure

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ischaemic Stroke

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Migraine

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Motor Dysfunction

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Optic Neuritis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

1 / 115 (0.87%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Presyncope

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

2 / 172 (1.16%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Autoimmune Haemolytic Anaemia

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Iron Deficiency Anaemia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Deafness Neurosensory

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Deafness Unilateral

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Cataract

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Retinal Detachment

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal Pain

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal Pain Upper

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anal Fissure

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anorectal Disorder

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis Ulcerative

subjects affected / exposed

11 / 319 (3.45%)

4 / 321 (1.25%)

4 / 233 (1.72%)

8 / 175 (4.57%)

1 / 172 (0.58%)

4 / 320 (1.25%)

5 / 184 (2.72%)

2 / 176 (1.14%)

3 / 115 (2.61%)

2 / 56 (3.57%)

1 / 141 (0.71%)

7 / 157 (4.46%)

3 / 103 (2.91%)

1 / 37 (2.70%)

3 / 64 (4.69%)

5 / 143 (3.50%)

4 / 73 (5.48%)

2 / 116 (1.72%)

occurrences causally related to treatment / all

0 / 12

1 / 4

0 / 4

0 / 8

0 / 1

0 / 4

0 / 5

0 / 2

0 / 3

0 / 2

0 / 1

0 / 8

3 / 5

0 / 1

0 / 3

0 / 6

0 / 4

0 / 2

deaths causally related to treatment / all

0 / 0

Colon Dysplasia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea Haemorrhagic

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Duodenal Ulcer

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enteritis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterovesical Fistula

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal Haemorrhage

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inguinal Hernia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large Intestinal Obstruction

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large Intestine Perforation

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large Intestine Polyp

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mesenteric Fibrosis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal Varices Haemorrhage

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pancreatitis Acute

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pseudopolyposis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small Intestinal Obstruction

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subileus

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

1 / 157 (0.64%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Umbilical Hernia

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholecystitis Acute

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholelithiasis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Drug-Induced Liver Injury

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Liver Disorder

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Dermatitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyoderma Gangrenosum

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rash

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute Kidney Injury

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Calculus Bladder

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic Kidney Disease

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Glomerulonephritis Chronic

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nephrolithiasis

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

1 / 184 (0.54%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal Colic

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Ureterolithiasis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

1 / 320 (0.31%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

2 / 116 (1.72%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Urinary Incontinence

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Enthesopathy

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intervertebral Disc Protrusion

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteoarthritis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rotator Cuff Syndrome

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sacroiliitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

1 / 64 (1.56%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Anal Abscess

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Appendicitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

1 / 103 (0.97%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

deaths causally related to treatment / all

0 / 0

Clostridium Difficile Infection

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Complicated Appendicitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cystitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cytomegalovirus Colitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

2 / 172 (1.16%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Cytomegalovirus Infection

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

2 / 56 (3.57%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Diverticulitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

1 / 233 (0.43%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Gastroenteritis Salmonella

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

1 / 184 (0.54%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatitis C

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Herpes Zoster

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Human Herpesvirus 6 Infection

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Influenza

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Listeriosis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neutropenic Sepsis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oral Herpes

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pelvic Inflammatory Disease

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Periorbital Cellulitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Perirectal Abscess

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pharyngeal Abscess

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 319 (0.00%)

1 / 321 (0.31%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

1 / 184 (0.54%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

1 / 141 (0.71%)

1 / 157 (0.64%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia Legionella

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

1 / 184 (0.54%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia Viral

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

1 / 115 (0.87%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

1 / 233 (0.43%)

0 / 175 (0.00%)

1 / 172 (0.58%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

1 / 116 (0.86%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Salpingitis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

1 / 176 (0.57%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Salpingo-Oophoritis

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

1 / 143 (0.70%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subcutaneous Abscess

subjects affected / exposed

1 / 319 (0.31%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tooth Abscess

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

1 / 73 (1.37%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetic Metabolic Decompensation

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

1 / 175 (0.57%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

0 / 56 (0.00%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Failure to Thrive

subjects affected / exposed

0 / 319 (0.00%)

0 / 321 (0.00%)

0 / 233 (0.00%)

0 / 175 (0.00%)

0 / 172 (0.00%)

0 / 320 (0.00%)

0 / 184 (0.00%)

0 / 176 (0.00%)

0 / 115 (0.00%)

1 / 56 (1.79%)

0 / 141 (0.00%)

0 / 157 (0.00%)

0 / 103 (0.00%)

0 / 37 (0.00%)

0 / 64 (0.00%)

0 / 143 (0.00%)

0 / 73 (0.00%)

0 / 116 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 milligram (mg) IV	IS: Ustekinumab Nonresponders at Week 8	Maintenance study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC every 12 weeks (q12w)	IS: Ustekinumab approximately 6mg/kg IV	IS: Placebo-Nonresponders at Week 8	MS: Ustekinumab 90mg SC every 8 weeks (q8w)	Long Term Extension (LTE): Placebo SC	LTE: Placebo SC to Ustekinumab SC 90 mg q8w	LTE: Ustekinumab 90 mg SC q12w	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w	MS: Placebo IV (IS – Responders) to Placebo SC	LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w	LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w	LTE: Ustekinumab 90 mg SC q8w	LTE: Placebo IV (IS – Responders) to Placebo SC	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w
Total subjects affected by non serious adverse events
subjects affected / exposed	91 / 319 (28.53%)	100 / 321 (31.15%)	30 / 233 (12.88%)	121 / 175 (69.14%)	93 / 172 (54.07%)	103 / 320 (32.19%)	27 / 184 (14.67%)	118 / 176 (67.05%)	68 / 115 (59.13%)	48 / 56 (85.71%)	98 / 141 (69.50%)	93 / 157 (59.24%)	69 / 103 (66.99%)	27 / 37 (72.97%)	38 / 64 (59.38%)	105 / 143 (73.43%)	45 / 73 (61.64%)	91 / 116 (78.45%)
Vascular disorders
Hypertension
subjects affected / exposed	5 / 319 (1.57%)	1 / 321 (0.31%)	0 / 233 (0.00%)	0 / 175 (0.00%)	4 / 172 (2.33%)	0 / 320 (0.00%)	0 / 184 (0.00%)	3 / 176 (1.70%)	1 / 115 (0.87%)	2 / 56 (3.57%)	5 / 141 (3.55%)	3 / 157 (1.91%)	1 / 103 (0.97%)	3 / 37 (8.11%)	1 / 64 (1.56%)	5 / 143 (3.50%)	3 / 73 (4.11%)	3 / 116 (2.59%)
occurrences all number	7	1	0	0	4	0	0	4	1	2	5	3	1	3	1	5	3	4
General disorders and administration site conditions
Fatigue
subjects affected / exposed	5 / 319 (1.57%)	6 / 321 (1.87%)	1 / 233 (0.43%)	4 / 175 (2.29%)	4 / 172 (2.33%)	8 / 320 (2.50%)	0 / 184 (0.00%)	7 / 176 (3.98%)	4 / 115 (3.48%)	1 / 56 (1.79%)	0 / 141 (0.00%)	3 / 157 (1.91%)	3 / 103 (2.91%)	1 / 37 (2.70%)	2 / 64 (3.13%)	5 / 143 (3.50%)	1 / 73 (1.37%)	2 / 116 (1.72%)
occurrences all number	5	6	1	6	4	8	0	10	4	1	0	4	3	2	2	5	1	2
Influenza Like Illness
subjects affected / exposed	2 / 319 (0.63%)	2 / 321 (0.62%)	1 / 233 (0.43%)	4 / 175 (2.29%)	2 / 172 (1.16%)	1 / 320 (0.31%)	1 / 184 (0.54%)	2 / 176 (1.14%)	1 / 115 (0.87%)	0 / 56 (0.00%)	2 / 141 (1.42%)	0 / 157 (0.00%)	0 / 103 (0.00%)	0 / 37 (0.00%)	0 / 64 (0.00%)	4 / 143 (2.80%)	1 / 73 (1.37%)	5 / 116 (4.31%)
occurrences all number	2	2	1	4	4	1	1	2	1	0	2	0	0	0	0	5	1	5
Injection Site Erythema
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	1 / 233 (0.43%)	1 / 175 (0.57%)	1 / 172 (0.58%)	0 / 320 (0.00%)	1 / 184 (0.54%)	3 / 176 (1.70%)	0 / 115 (0.00%)	0 / 56 (0.00%)	1 / 141 (0.71%)	3 / 157 (1.91%)	0 / 103 (0.00%)	1 / 37 (2.70%)	0 / 64 (0.00%)	5 / 143 (3.50%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	0	0	1	1	1	0	1	3	0	0	1	4	0	2	0	7	0	5
Injection Site Swelling
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	1 / 157 (0.64%)	0 / 103 (0.00%)	2 / 37 (5.41%)	0 / 64 (0.00%)	1 / 143 (0.70%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	2	0	3	0	1	0	0
Pyrexia
subjects affected / exposed	6 / 319 (1.88%)	4 / 321 (1.25%)	0 / 233 (0.00%)	7 / 175 (4.00%)	1 / 172 (0.58%)	6 / 320 (1.88%)	1 / 184 (0.54%)	8 / 176 (4.55%)	2 / 115 (1.74%)	3 / 56 (5.36%)	0 / 141 (0.00%)	5 / 157 (3.18%)	5 / 103 (4.85%)	0 / 37 (0.00%)	0 / 64 (0.00%)	1 / 143 (0.70%)	2 / 73 (2.74%)	7 / 116 (6.03%)
occurrences all number	6	4	0	7	1	8	1	8	2	3	0	5	6	0	0	1	4	7
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	3 / 319 (0.94%)	4 / 321 (1.25%)	0 / 233 (0.00%)	5 / 175 (2.86%)	2 / 172 (1.16%)	3 / 320 (0.94%)	0 / 184 (0.00%)	7 / 176 (3.98%)	5 / 115 (4.35%)	5 / 56 (8.93%)	2 / 141 (1.42%)	4 / 157 (2.55%)	4 / 103 (3.88%)	1 / 37 (2.70%)	2 / 64 (3.13%)	7 / 143 (4.90%)	1 / 73 (1.37%)	4 / 116 (3.45%)
occurrences all number	3	4	0	7	3	3	0	8	5	5	3	4	4	1	2	7	1	6
Oropharyngeal Pain
subjects affected / exposed	1 / 319 (0.31%)	1 / 321 (0.31%)	0 / 233 (0.00%)	5 / 175 (2.86%)	4 / 172 (2.33%)	8 / 320 (2.50%)	1 / 184 (0.54%)	7 / 176 (3.98%)	0 / 115 (0.00%)	1 / 56 (1.79%)	7 / 141 (4.96%)	1 / 157 (0.64%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	5 / 143 (3.50%)	1 / 73 (1.37%)	3 / 116 (2.59%)
occurrences all number	1	1	0	7	4	8	1	8	0	1	7	1	1	0	0	5	1	3
Psychiatric disorders
Anxiety
subjects affected / exposed	4 / 319 (1.25%)	1 / 321 (0.31%)	0 / 233 (0.00%)	2 / 175 (1.14%)	3 / 172 (1.74%)	0 / 320 (0.00%)	1 / 184 (0.54%)	3 / 176 (1.70%)	0 / 115 (0.00%)	1 / 56 (1.79%)	0 / 141 (0.00%)	0 / 157 (0.00%)	4 / 103 (3.88%)	0 / 37 (0.00%)	0 / 64 (0.00%)	2 / 143 (1.40%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	4	1	0	2	3	0	1	3	0	1	0	0	4	0	0	2	0	1
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	2 / 319 (0.63%)	0 / 321 (0.00%)	0 / 233 (0.00%)	4 / 175 (2.29%)	5 / 172 (2.91%)	6 / 320 (1.88%)	0 / 184 (0.00%)	6 / 176 (3.41%)	0 / 115 (0.00%)	7 / 56 (12.50%)	3 / 141 (2.13%)	1 / 157 (0.64%)	3 / 103 (2.91%)	1 / 37 (2.70%)	3 / 64 (4.69%)	3 / 143 (2.10%)	0 / 73 (0.00%)	4 / 116 (3.45%)
occurrences all number	2	0	0	5	5	7	0	7	0	7	5	1	3	1	4	3	0	8
Aspartate Aminotransferase Increased
subjects affected / exposed	2 / 319 (0.63%)	0 / 321 (0.00%)	0 / 233 (0.00%)	4 / 175 (2.29%)	5 / 172 (2.91%)	3 / 320 (0.94%)	0 / 184 (0.00%)	4 / 176 (2.27%)	0 / 115 (0.00%)	5 / 56 (8.93%)	1 / 141 (0.71%)	3 / 157 (1.91%)	4 / 103 (3.88%)	1 / 37 (2.70%)	3 / 64 (4.69%)	4 / 143 (2.80%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	2	0	0	5	6	3	0	4	0	5	2	4	4	1	3	4	0	5
Blood Alkaline Phosphatase Increased
subjects affected / exposed	1 / 319 (0.31%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	1 / 172 (0.58%)	2 / 320 (0.63%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	2 / 56 (3.57%)	1 / 141 (0.71%)	2 / 157 (1.27%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	1	0	0	1	1	2	0	1	0	2	2	2	1	0	0	0	0	0
Blood Phosphorus Decreased
subjects affected / exposed	1 / 319 (0.31%)	1 / 321 (0.31%)	1 / 233 (0.43%)	1 / 175 (0.57%)	1 / 172 (0.58%)	1 / 320 (0.31%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	1 / 157 (0.64%)	1 / 103 (0.97%)	1 / 37 (2.70%)	2 / 64 (3.13%)	0 / 143 (0.00%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	1	1	1	1	1	1	0	1	0	0	0	1	1	1	2	0	0	0
Stool Analysis Abnormal
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	4 / 56 (7.14%)	1 / 141 (0.71%)	0 / 157 (0.00%)	0 / 103 (0.00%)	2 / 37 (5.41%)	1 / 64 (1.56%)	3 / 143 (2.10%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	0	0	0	0	0	0	0	0	0	6	1	0	0	2	1	3	0	1
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	0 / 319 (0.00%)	1 / 321 (0.31%)	0 / 233 (0.00%)	0 / 175 (0.00%)	2 / 172 (1.16%)	2 / 320 (0.63%)	0 / 184 (0.00%)	4 / 176 (2.27%)	0 / 115 (0.00%)	2 / 56 (3.57%)	1 / 141 (0.71%)	1 / 157 (0.64%)	0 / 103 (0.00%)	0 / 37 (0.00%)	0 / 64 (0.00%)	3 / 143 (2.10%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	0	1	0	0	2	2	0	5	0	3	1	2	0	0	0	3	0	2
Heat Illness
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	2 / 56 (3.57%)	0 / 141 (0.00%)	1 / 157 (0.64%)	0 / 103 (0.00%)	0 / 37 (0.00%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0	1
Ligament Sprain
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	1 / 115 (0.87%)	0 / 56 (0.00%)	1 / 141 (0.71%)	1 / 157 (0.64%)	1 / 103 (0.97%)	2 / 37 (5.41%)	1 / 64 (1.56%)	0 / 143 (0.00%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	1	1	2	1	0	0	2
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 319 (0.31%)	2 / 321 (0.62%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	4 / 320 (1.25%)	0 / 184 (0.00%)	3 / 176 (1.70%)	1 / 115 (0.87%)	1 / 56 (1.79%)	2 / 141 (1.42%)	2 / 157 (1.27%)	0 / 103 (0.00%)	1 / 37 (2.70%)	2 / 64 (3.13%)	0 / 143 (0.00%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	1	2	0	0	0	4	0	3	1	1	2	2	0	1	2	0	0	1
Headache
subjects affected / exposed	14 / 319 (4.39%)	22 / 321 (6.85%)	2 / 233 (0.86%)	7 / 175 (4.00%)	11 / 172 (6.40%)	13 / 320 (4.06%)	2 / 184 (1.09%)	18 / 176 (10.23%)	7 / 115 (6.09%)	4 / 56 (7.14%)	9 / 141 (6.38%)	9 / 157 (5.73%)	4 / 103 (3.88%)	2 / 37 (5.41%)	2 / 64 (3.13%)	11 / 143 (7.69%)	4 / 73 (5.48%)	11 / 116 (9.48%)
occurrences all number	17	24	2	7	22	16	2	27	10	5	9	21	4	3	2	15	4	14
Migraine
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	3 / 175 (1.71%)	1 / 172 (0.58%)	0 / 320 (0.00%)	0 / 184 (0.00%)	2 / 176 (1.14%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	2 / 157 (1.27%)	0 / 103 (0.00%)	0 / 37 (0.00%)	2 / 64 (3.13%)	2 / 143 (1.40%)	1 / 73 (1.37%)	2 / 116 (1.72%)
occurrences all number	0	0	0	3	1	0	0	3	0	0	0	3	0	0	2	6	1	16
Tremor
subjects affected / exposed	0 / 319 (0.00%)	1 / 321 (0.31%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	0 / 157 (0.00%)	1 / 103 (0.97%)	2 / 37 (5.41%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	11 / 319 (3.45%)	7 / 321 (2.18%)	1 / 233 (0.43%)	12 / 175 (6.86%)	7 / 172 (4.07%)	8 / 320 (2.50%)	4 / 184 (2.17%)	7 / 176 (3.98%)	1 / 115 (0.87%)	3 / 56 (5.36%)	4 / 141 (2.84%)	9 / 157 (5.73%)	9 / 103 (8.74%)	1 / 37 (2.70%)	3 / 64 (4.69%)	2 / 143 (1.40%)	3 / 73 (4.11%)	4 / 116 (3.45%)
occurrences all number	11	10	1	13	8	8	4	7	1	3	4	9	9	1	4	2	3	6
Leukopenia
subjects affected / exposed	1 / 319 (0.31%)	2 / 321 (0.62%)	1 / 233 (0.43%)	3 / 175 (1.71%)	2 / 172 (1.16%)	5 / 320 (1.56%)	0 / 184 (0.00%)	3 / 176 (1.70%)	0 / 115 (0.00%)	2 / 56 (3.57%)	3 / 141 (2.13%)	5 / 157 (3.18%)	4 / 103 (3.88%)	0 / 37 (0.00%)	0 / 64 (0.00%)	0 / 143 (0.00%)	2 / 73 (2.74%)	3 / 116 (2.59%)
occurrences all number	1	2	1	5	2	5	0	3	0	2	4	7	5	0	0	0	3	4
Neutropenia
subjects affected / exposed	1 / 319 (0.31%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	1 / 172 (0.58%)	1 / 320 (0.31%)	0 / 184 (0.00%)	2 / 176 (1.14%)	1 / 115 (0.87%)	2 / 56 (3.57%)	1 / 141 (0.71%)	4 / 157 (2.55%)	3 / 103 (2.91%)	0 / 37 (0.00%)	0 / 64 (0.00%)	2 / 143 (1.40%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	1	0	0	3	1	1	0	3	1	3	1	6	3	0	0	2	0	4
Eye disorders
Cataract
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	2 / 172 (1.16%)	1 / 320 (0.31%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	0 / 56 (0.00%)	1 / 141 (0.71%)	3 / 157 (1.91%)	1 / 103 (0.97%)	0 / 37 (0.00%)	2 / 64 (3.13%)	0 / 143 (0.00%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	0	0	0	1	3	1	0	1	0	0	1	4	1	0	2	0	0	1
Gastrointestinal disorders
Abdominal Distension
subjects affected / exposed	0 / 319 (0.00%)	2 / 321 (0.62%)	1 / 233 (0.43%)	4 / 175 (2.29%)	2 / 172 (1.16%)	0 / 320 (0.00%)	0 / 184 (0.00%)	5 / 176 (2.84%)	0 / 115 (0.00%)	3 / 56 (5.36%)	2 / 141 (1.42%)	1 / 157 (0.64%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	5 / 143 (3.50%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	0	2	1	4	2	0	0	5	0	3	2	1	1	0	0	5	0	4
Abdominal Pain
subjects affected / exposed	9 / 319 (2.82%)	8 / 321 (2.49%)	0 / 233 (0.00%)	4 / 175 (2.29%)	6 / 172 (3.49%)	5 / 320 (1.56%)	0 / 184 (0.00%)	8 / 176 (4.55%)	2 / 115 (1.74%)	1 / 56 (1.79%)	2 / 141 (1.42%)	5 / 157 (3.18%)	3 / 103 (2.91%)	1 / 37 (2.70%)	2 / 64 (3.13%)	15 / 143 (10.49%)	4 / 73 (5.48%)	5 / 116 (4.31%)
occurrences all number	9	9	0	9	6	5	0	9	2	1	3	7	3	1	2	24	5	5
Abdominal Pain Upper
subjects affected / exposed	0 / 319 (0.00%)	4 / 321 (1.25%)	2 / 233 (0.86%)	1 / 175 (0.57%)	0 / 172 (0.00%)	1 / 320 (0.31%)	0 / 184 (0.00%)	4 / 176 (2.27%)	3 / 115 (2.61%)	2 / 56 (3.57%)	4 / 141 (2.84%)	1 / 157 (0.64%)	1 / 103 (0.97%)	1 / 37 (2.70%)	1 / 64 (1.56%)	2 / 143 (1.40%)	1 / 73 (1.37%)	2 / 116 (1.72%)
occurrences all number	0	4	2	1	0	1	0	5	3	2	4	2	1	1	1	2	1	2
Colitis Ulcerative
subjects affected / exposed	8 / 319 (2.51%)	5 / 321 (1.56%)	3 / 233 (1.29%)	48 / 175 (27.43%)	19 / 172 (11.05%)	5 / 320 (1.56%)	1 / 184 (0.54%)	16 / 176 (9.09%)	23 / 115 (20.00%)	11 / 56 (19.64%)	34 / 141 (24.11%)	23 / 157 (14.65%)	25 / 103 (24.27%)	13 / 37 (35.14%)	20 / 64 (31.25%)	37 / 143 (25.87%)	27 / 73 (36.99%)	30 / 116 (25.86%)
occurrences all number	8	5	3	57	23	5	1	18	27	12	40	27	30	19	26	43	31	39
Constipation
subjects affected / exposed	1 / 319 (0.31%)	1 / 321 (0.31%)	0 / 233 (0.00%)	6 / 175 (3.43%)	0 / 172 (0.00%)	1 / 320 (0.31%)	1 / 184 (0.54%)	3 / 176 (1.70%)	1 / 115 (0.87%)	1 / 56 (1.79%)	1 / 141 (0.71%)	0 / 157 (0.00%)	1 / 103 (0.97%)	1 / 37 (2.70%)	0 / 64 (0.00%)	5 / 143 (3.50%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	1	1	0	6	0	1	1	3	1	1	1	0	2	1	0	5	0	2
Diarrhoea
subjects affected / exposed	1 / 319 (0.31%)	3 / 321 (0.93%)	0 / 233 (0.00%)	2 / 175 (1.14%)	5 / 172 (2.91%)	1 / 320 (0.31%)	0 / 184 (0.00%)	7 / 176 (3.98%)	2 / 115 (1.74%)	1 / 56 (1.79%)	6 / 141 (4.26%)	6 / 157 (3.82%)	2 / 103 (1.94%)	2 / 37 (5.41%)	3 / 64 (4.69%)	13 / 143 (9.09%)	4 / 73 (5.48%)	9 / 116 (7.76%)
occurrences all number	1	3	0	2	5	2	0	7	2	1	7	6	2	2	3	17	4	12
Frequent Bowel Movements
subjects affected / exposed	0 / 319 (0.00%)	3 / 321 (0.93%)	0 / 233 (0.00%)	0 / 175 (0.00%)	1 / 172 (0.58%)	1 / 320 (0.31%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	1 / 56 (1.79%)	1 / 141 (0.71%)	0 / 157 (0.00%)	0 / 103 (0.00%)	2 / 37 (5.41%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	0	4	0	0	1	1	0	1	0	1	1	0	0	2	0	0	0	2
Nausea
subjects affected / exposed	7 / 319 (2.19%)	8 / 321 (2.49%)	3 / 233 (1.29%)	4 / 175 (2.29%)	4 / 172 (2.33%)	7 / 320 (2.19%)	3 / 184 (1.63%)	6 / 176 (3.41%)	2 / 115 (1.74%)	1 / 56 (1.79%)	5 / 141 (3.55%)	5 / 157 (3.18%)	3 / 103 (2.91%)	1 / 37 (2.70%)	1 / 64 (1.56%)	9 / 143 (6.29%)	1 / 73 (1.37%)	5 / 116 (4.31%)
occurrences all number	7	8	3	4	5	7	3	9	2	1	6	5	3	1	1	11	1	6
Rectal Haemorrhage
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	2 / 56 (3.57%)	0 / 141 (0.00%)	0 / 157 (0.00%)	1 / 103 (0.97%)	3 / 37 (8.11%)	0 / 64 (0.00%)	2 / 143 (1.40%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	2	0	0	0	2	0	2	0	0	1	3	0	2	0	0
Vomiting
subjects affected / exposed	1 / 319 (0.31%)	3 / 321 (0.93%)	3 / 233 (1.29%)	5 / 175 (2.86%)	1 / 172 (0.58%)	4 / 320 (1.25%)	0 / 184 (0.00%)	1 / 176 (0.57%)	3 / 115 (2.61%)	2 / 56 (3.57%)	0 / 141 (0.00%)	3 / 157 (1.91%)	0 / 103 (0.00%)	0 / 37 (0.00%)	1 / 64 (1.56%)	6 / 143 (4.20%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	1	3	3	5	1	9	0	1	3	2	0	3	0	0	1	7	0	2
Hepatobiliary disorders
Hepatic Steatosis
subjects affected / exposed	1 / 319 (0.31%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	1 / 172 (0.58%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	1 / 115 (0.87%)	2 / 56 (3.57%)	0 / 141 (0.00%)	0 / 157 (0.00%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	1	0	0	1	1	0	0	0	1	2	0	0	1	0	0	0	0	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	3 / 319 (0.94%)	1 / 321 (0.31%)	0 / 233 (0.00%)	0 / 175 (0.00%)	2 / 172 (1.16%)	2 / 320 (0.63%)	0 / 184 (0.00%)	3 / 176 (1.70%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	0 / 157 (0.00%)	4 / 103 (3.88%)	1 / 37 (2.70%)	0 / 64 (0.00%)	1 / 143 (0.70%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	3	1	0	0	2	4	0	3	0	0	0	0	4	1	0	1	0	0
Eczema
subjects affected / exposed	5 / 319 (1.57%)	1 / 321 (0.31%)	1 / 233 (0.43%)	5 / 175 (2.86%)	0 / 172 (0.00%)	2 / 320 (0.63%)	0 / 184 (0.00%)	3 / 176 (1.70%)	0 / 115 (0.00%)	2 / 56 (3.57%)	1 / 141 (0.71%)	0 / 157 (0.00%)	2 / 103 (1.94%)	1 / 37 (2.70%)	0 / 64 (0.00%)	2 / 143 (1.40%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	5	2	1	5	0	2	0	3	0	2	1	0	2	1	0	4	0	3
Papule
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	2 / 175 (1.14%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	2 / 56 (3.57%)	0 / 141 (0.00%)	0 / 157 (0.00%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	0 / 143 (0.00%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	2	0	0	1	0	0	0	0	0
Pruritus
subjects affected / exposed	4 / 319 (1.25%)	8 / 321 (2.49%)	0 / 233 (0.00%)	4 / 175 (2.29%)	1 / 172 (0.58%)	3 / 320 (0.94%)	1 / 184 (0.54%)	2 / 176 (1.14%)	1 / 115 (0.87%)	1 / 56 (1.79%)	1 / 141 (0.71%)	2 / 157 (1.27%)	3 / 103 (2.91%)	0 / 37 (0.00%)	2 / 64 (3.13%)	2 / 143 (1.40%)	0 / 73 (0.00%)	3 / 116 (2.59%)
occurrences all number	4	8	0	4	1	3	1	2	1	1	1	2	3	0	2	2	0	4
Rash
subjects affected / exposed	1 / 319 (0.31%)	3 / 321 (0.93%)	2 / 233 (0.86%)	6 / 175 (3.43%)	6 / 172 (3.49%)	4 / 320 (1.25%)	1 / 184 (0.54%)	6 / 176 (3.41%)	0 / 115 (0.00%)	1 / 56 (1.79%)	2 / 141 (1.42%)	2 / 157 (1.27%)	2 / 103 (1.94%)	1 / 37 (2.70%)	1 / 64 (1.56%)	5 / 143 (3.50%)	6 / 73 (8.22%)	3 / 116 (2.59%)
occurrences all number	1	3	3	7	8	6	1	6	0	1	3	2	2	1	1	5	7	3
Skin Lesion
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	1 / 320 (0.31%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	2 / 56 (3.57%)	0 / 141 (0.00%)	0 / 157 (0.00%)	0 / 103 (0.00%)	0 / 37 (0.00%)	0 / 64 (0.00%)	1 / 143 (0.70%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	2	0	0	0	0	0	2	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 319 (0.94%)	4 / 321 (1.25%)	2 / 233 (0.86%)	17 / 175 (9.71%)	16 / 172 (9.30%)	6 / 320 (1.88%)	1 / 184 (0.54%)	10 / 176 (5.68%)	6 / 115 (5.22%)	4 / 56 (7.14%)	9 / 141 (6.38%)	16 / 157 (10.19%)	9 / 103 (8.74%)	2 / 37 (5.41%)	5 / 64 (7.81%)	11 / 143 (7.69%)	4 / 73 (5.48%)	10 / 116 (8.62%)
occurrences all number	3	4	2	18	18	6	1	16	6	5	9	19	13	3	6	13	4	12
Back Pain
subjects affected / exposed	4 / 319 (1.25%)	2 / 321 (0.62%)	1 / 233 (0.43%)	7 / 175 (4.00%)	1 / 172 (0.58%)	4 / 320 (1.25%)	0 / 184 (0.00%)	7 / 176 (3.98%)	5 / 115 (4.35%)	6 / 56 (10.71%)	7 / 141 (4.96%)	5 / 157 (3.18%)	3 / 103 (2.91%)	2 / 37 (5.41%)	3 / 64 (4.69%)	7 / 143 (4.90%)	5 / 73 (6.85%)	6 / 116 (5.17%)
occurrences all number	5	2	1	8	1	4	0	8	5	8	8	5	3	2	3	9	6	7
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 319 (0.31%)	0 / 321 (0.00%)	0 / 233 (0.00%)	6 / 175 (3.43%)	5 / 172 (2.91%)	2 / 320 (0.63%)	1 / 184 (0.54%)	6 / 176 (3.41%)	2 / 115 (1.74%)	3 / 56 (5.36%)	7 / 141 (4.96%)	6 / 157 (3.82%)	5 / 103 (4.85%)	0 / 37 (0.00%)	2 / 64 (3.13%)	4 / 143 (2.80%)	0 / 73 (0.00%)	6 / 116 (5.17%)
occurrences all number	1	0	0	6	5	2	1	6	2	5	9	7	5	0	2	7	0	7
Covid-19
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	0 / 157 (0.00%)	0 / 103 (0.00%)	1 / 37 (2.70%)	0 / 64 (0.00%)	3 / 143 (2.10%)	0 / 73 (0.00%)	4 / 116 (3.45%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	3	0	4
Ear Infection
subjects affected / exposed	0 / 319 (0.00%)	1 / 321 (0.31%)	0 / 233 (0.00%)	0 / 175 (0.00%)	1 / 172 (0.58%)	0 / 320 (0.00%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	0 / 56 (0.00%)	1 / 141 (0.71%)	0 / 157 (0.00%)	0 / 103 (0.00%)	2 / 37 (5.41%)	0 / 64 (0.00%)	4 / 143 (2.80%)	0 / 73 (0.00%)	2 / 116 (1.72%)
occurrences all number	0	1	0	0	1	0	0	2	0	0	1	0	0	2	0	4	0	2
Gastroenteritis
subjects affected / exposed	2 / 319 (0.63%)	2 / 321 (0.62%)	0 / 233 (0.00%)	5 / 175 (2.86%)	5 / 172 (2.91%)	1 / 320 (0.31%)	0 / 184 (0.00%)	7 / 176 (3.98%)	1 / 115 (0.87%)	2 / 56 (3.57%)	4 / 141 (2.84%)	5 / 157 (3.18%)	2 / 103 (1.94%)	3 / 37 (8.11%)	0 / 64 (0.00%)	5 / 143 (3.50%)	2 / 73 (2.74%)	8 / 116 (6.90%)
occurrences all number	2	2	0	5	6	1	0	7	1	3	4	6	2	3	0	5	4	9
Herpes Zoster
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	4 / 175 (2.29%)	0 / 172 (0.00%)	2 / 320 (0.63%)	1 / 184 (0.54%)	2 / 176 (1.14%)	0 / 115 (0.00%)	0 / 56 (0.00%)	0 / 141 (0.00%)	0 / 157 (0.00%)	0 / 103 (0.00%)	0 / 37 (0.00%)	2 / 64 (3.13%)	3 / 143 (2.10%)	0 / 73 (0.00%)	5 / 116 (4.31%)
occurrences all number	0	0	0	4	0	2	1	2	0	0	0	0	0	0	2	3	0	6
Influenza
subjects affected / exposed	0 / 319 (0.00%)	2 / 321 (0.62%)	2 / 233 (0.86%)	8 / 175 (4.57%)	5 / 172 (2.91%)	1 / 320 (0.31%)	0 / 184 (0.00%)	10 / 176 (5.68%)	4 / 115 (3.48%)	4 / 56 (7.14%)	6 / 141 (4.26%)	7 / 157 (4.46%)	6 / 103 (5.83%)	3 / 37 (8.11%)	3 / 64 (4.69%)	10 / 143 (6.99%)	6 / 73 (8.22%)	3 / 116 (2.59%)
occurrences all number	0	2	2	9	5	1	0	11	4	4	6	7	6	4	3	12	6	5
Laryngitis
subjects affected / exposed	1 / 319 (0.31%)	0 / 321 (0.00%)	0 / 233 (0.00%)	1 / 175 (0.57%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	1 / 115 (0.87%)	2 / 56 (3.57%)	0 / 141 (0.00%)	0 / 157 (0.00%)	0 / 103 (0.00%)	0 / 37 (0.00%)	0 / 64 (0.00%)	1 / 143 (0.70%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	1	2	0	0	0	0	0	1	0	0
Nasopharyngitis
subjects affected / exposed	9 / 319 (2.82%)	13 / 321 (4.05%)	1 / 233 (0.43%)	28 / 175 (16.00%)	31 / 172 (18.02%)	18 / 320 (5.63%)	7 / 184 (3.80%)	26 / 176 (14.77%)	17 / 115 (14.78%)	13 / 56 (23.21%)	29 / 141 (20.57%)	19 / 157 (12.10%)	13 / 103 (12.62%)	12 / 37 (32.43%)	10 / 64 (15.63%)	27 / 143 (18.88%)	5 / 73 (6.85%)	32 / 116 (27.59%)
occurrences all number	9	13	1	39	45	18	7	38	21	28	51	20	18	14	16	52	10	55
Oral Herpes
subjects affected / exposed	5 / 319 (1.57%)	1 / 321 (0.31%)	0 / 233 (0.00%)	1 / 175 (0.57%)	1 / 172 (0.58%)	3 / 320 (0.94%)	0 / 184 (0.00%)	3 / 176 (1.70%)	0 / 115 (0.00%)	1 / 56 (1.79%)	3 / 141 (2.13%)	0 / 157 (0.00%)	2 / 103 (1.94%)	2 / 37 (5.41%)	1 / 64 (1.56%)	6 / 143 (4.20%)	4 / 73 (5.48%)	0 / 116 (0.00%)
occurrences all number	5	1	0	1	2	4	0	6	0	1	4	0	4	2	2	9	6	0
Pharyngitis
subjects affected / exposed	1 / 319 (0.31%)	1 / 321 (0.31%)	0 / 233 (0.00%)	2 / 175 (1.14%)	3 / 172 (1.74%)	0 / 320 (0.00%)	1 / 184 (0.54%)	2 / 176 (1.14%)	1 / 115 (0.87%)	0 / 56 (0.00%)	3 / 141 (2.13%)	2 / 157 (1.27%)	4 / 103 (3.88%)	2 / 37 (5.41%)	1 / 64 (1.56%)	3 / 143 (2.10%)	3 / 73 (4.11%)	0 / 116 (0.00%)
occurrences all number	2	1	0	2	3	0	1	2	1	0	4	2	4	3	1	3	3	0
Rhinitis
subjects affected / exposed	0 / 319 (0.00%)	3 / 321 (0.93%)	1 / 233 (0.43%)	2 / 175 (1.14%)	2 / 172 (1.16%)	1 / 320 (0.31%)	1 / 184 (0.54%)	4 / 176 (2.27%)	2 / 115 (1.74%)	2 / 56 (3.57%)	2 / 141 (1.42%)	1 / 157 (0.64%)	0 / 103 (0.00%)	0 / 37 (0.00%)	1 / 64 (1.56%)	2 / 143 (1.40%)	0 / 73 (0.00%)	1 / 116 (0.86%)
occurrences all number	0	3	1	2	2	1	1	4	2	2	3	1	0	0	2	2	0	1
Sinusitis
subjects affected / exposed	1 / 319 (0.31%)	5 / 321 (1.56%)	1 / 233 (0.43%)	2 / 175 (1.14%)	2 / 172 (1.16%)	1 / 320 (0.31%)	0 / 184 (0.00%)	7 / 176 (3.98%)	3 / 115 (2.61%)	2 / 56 (3.57%)	5 / 141 (3.55%)	3 / 157 (1.91%)	1 / 103 (0.97%)	4 / 37 (10.81%)	1 / 64 (1.56%)	8 / 143 (5.59%)	1 / 73 (1.37%)	4 / 116 (3.45%)
occurrences all number	1	5	1	2	3	1	0	11	3	3	7	3	1	4	1	15	1	5
Tonsillitis
subjects affected / exposed	0 / 319 (0.00%)	1 / 321 (0.31%)	0 / 233 (0.00%)	2 / 175 (1.14%)	2 / 172 (1.16%)	1 / 320 (0.31%)	0 / 184 (0.00%)	1 / 176 (0.57%)	1 / 115 (0.87%)	1 / 56 (1.79%)	3 / 141 (2.13%)	0 / 157 (0.00%)	2 / 103 (1.94%)	1 / 37 (2.70%)	0 / 64 (0.00%)	3 / 143 (2.10%)	1 / 73 (1.37%)	6 / 116 (5.17%)
occurrences all number	0	1	0	2	3	1	0	1	1	1	6	0	2	2	0	4	2	6
Upper Respiratory Tract Infection
subjects affected / exposed	4 / 319 (1.25%)	6 / 321 (1.87%)	5 / 233 (2.15%)	8 / 175 (4.57%)	5 / 172 (2.91%)	5 / 320 (1.56%)	2 / 184 (1.09%)	16 / 176 (9.09%)	6 / 115 (5.22%)	4 / 56 (7.14%)	12 / 141 (8.51%)	7 / 157 (4.46%)	4 / 103 (3.88%)	2 / 37 (5.41%)	4 / 64 (6.25%)	17 / 143 (11.89%)	4 / 73 (5.48%)	10 / 116 (8.62%)
occurrences all number	6	6	5	9	5	5	2	21	6	5	14	9	5	2	5	26	4	17
Urinary Tract Infection
subjects affected / exposed	0 / 319 (0.00%)	3 / 321 (0.93%)	0 / 233 (0.00%)	4 / 175 (2.29%)	3 / 172 (1.74%)	3 / 320 (0.94%)	1 / 184 (0.54%)	2 / 176 (1.14%)	2 / 115 (1.74%)	2 / 56 (3.57%)	0 / 141 (0.00%)	4 / 157 (2.55%)	2 / 103 (1.94%)	3 / 37 (8.11%)	3 / 64 (4.69%)	6 / 143 (4.20%)	1 / 73 (1.37%)	3 / 116 (2.59%)
occurrences all number	0	3	0	5	7	3	1	2	2	2	0	5	2	3	4	9	1	3
Viral Infection
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	2 / 175 (1.14%)	2 / 172 (1.16%)	0 / 320 (0.00%)	2 / 184 (1.09%)	3 / 176 (1.70%)	2 / 115 (1.74%)	0 / 56 (0.00%)	3 / 141 (2.13%)	1 / 157 (0.64%)	1 / 103 (0.97%)	2 / 37 (5.41%)	0 / 64 (0.00%)	3 / 143 (2.10%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	2	2	0	2	3	2	0	3	1	1	2	0	3	0	0
Viral Upper Respiratory Tract Infection
subjects affected / exposed	0 / 319 (0.00%)	1 / 321 (0.31%)	0 / 233 (0.00%)	2 / 175 (1.14%)	1 / 172 (0.58%)	0 / 320 (0.00%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	1 / 56 (1.79%)	0 / 141 (0.00%)	1 / 157 (0.64%)	2 / 103 (1.94%)	0 / 37 (0.00%)	2 / 64 (3.13%)	0 / 143 (0.00%)	1 / 73 (1.37%)	3 / 116 (2.59%)
occurrences all number	0	1	0	2	1	0	0	1	0	1	0	1	2	0	2	0	1	3
Metabolism and nutrition disorders
Iron Deficiency
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	1 / 233 (0.43%)	1 / 175 (0.57%)	1 / 172 (0.58%)	0 / 320 (0.00%)	0 / 184 (0.00%)	0 / 176 (0.00%)	1 / 115 (0.87%)	1 / 56 (1.79%)	1 / 141 (0.71%)	1 / 157 (0.64%)	1 / 103 (0.97%)	2 / 37 (5.41%)	1 / 64 (1.56%)	4 / 143 (2.80%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	1	1	1	0	0	0	1	1	1	1	1	2	1	4	0	0
Vitamin D Deficiency
subjects affected / exposed	0 / 319 (0.00%)	0 / 321 (0.00%)	0 / 233 (0.00%)	0 / 175 (0.00%)	0 / 172 (0.00%)	0 / 320 (0.00%)	0 / 184 (0.00%)	1 / 176 (0.57%)	0 / 115 (0.00%)	1 / 56 (1.79%)	1 / 141 (0.71%)	0 / 157 (0.00%)	1 / 103 (0.97%)	0 / 37 (0.00%)	0 / 64 (0.00%)	5 / 143 (3.50%)	0 / 73 (0.00%)	0 / 116 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	1	0	1	0	0	6	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

14 Jul 2015

To address health authority feedback and provide additional clarifications.

20 Apr 2016

To address health authority requests for additional data collection as well as to address investigator feedback and to provide further clarifications on the protocol.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter study to Evaluate the Safety and Efficacy of Ustekinumab Induction and MaintenanceTherapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per Global Definition)

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per Global Definition)

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per US Definition)

Primary: Induction Study - Number of Subjects with Clinical Remission at Week 8 (As per US Definition)

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (As per Global Definition)

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (As per Global Definition)

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (as per US Definition)

Primary: Maintenance Study: Number of Subjects with Clinical Remission at Week 44 (as per US Definition)

Secondary: Induction Study: Number of Subjects with Endoscopic Healing (EH) at Week 8

Secondary: Induction Study: Number of Subjects with Endoscopic Healing (EH) at Week 8

Secondary: Induction Study: Number of Subjects with Clinical Response at Week 8

Secondary: Induction Study: Number of Subjects with Clinical Response at Week 8

Secondary: Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

Secondary: Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

Secondary: Maintenance Study: Number of Subjects with Clinical Response up to Week 44

Secondary: Maintenance Study: Number of Subjects with Clinical Response up to Week 44

Secondary: Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44

Secondary: Maintenance Study: Number of Subjects with Endoscopic Healing at Week 44

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per Global Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per Global Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per US Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission and not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As per US Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Participants who Achieved Clinical Remission at Maintenance Study Baseline (As per Global Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Participants who Achieved Clinical Remission at Maintenance Study Baseline (As per Global Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Subjects who Achieved Clinical Remission at Maintenance Study Baseline (As per US Definition)

Secondary: Maintenance Study: Number of Subjects with Clinical Remission up to Week 44 Among Subjects who Achieved Clinical Remission at Maintenance Study Baseline (As per US Definition)

Secondary: Induction Study - Number of Subjects with Mucosal Healing at Week 8

Secondary: Induction Study - Number of Subjects with Mucosal Healing at Week 8

Secondary: Induction Study - Number of Subjects in Clinical Remission with a Rectal Bleeding Subscore of 0 at Week 8 (As per Global Definition)

Secondary: Induction Study - Number of Subjects in Clinical Remission with a Rectal Bleeding Subscore of 0 at Week 8 (As per Global Definition)

Secondary: Induction Study - Number of Subjects in Symptomatic Remission at Week 8

Secondary: Induction Study - Number of Subjects in Symptomatic Remission at Week 8

Secondary: Induction Study - Number of Subjects in with Normal or Inactive Mucosal Disease at Week 8

Secondary: Induction Study - Number of Subjects in with Normal or Inactive Mucosal Disease at Week 8

Secondary: Induction Study - Change from Baseline in Mayo score at Week 8

Secondary: Induction Study - Change from Baseline in Mayo score at Week 8

Secondary: Induction Study - Change from Baseline in Partial Mayo Score Through Week 8

Secondary: Induction Study - Change from Baseline in Partial Mayo Score Through Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Stool Frequency) up to Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Stool Frequency) up to Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Rectal Bleeding) up to Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 8

Secondary: Induction Study - Number of Subjects with individual Mayo Subscore (Endoscopy Findings) at Week 8

Secondary: Induction Study - Number of Subjects with Individual Mayo Subscore (Physician's Global Assessment) up to Week 8

Secondary: Induction Study - Number of Subjects with Individual Mayo Subscore (Physician's Global Assessment) up to Week 8

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per Global Definition)

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per Global Definition)

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per US Definition)

Secondary: Induction Study - Number of Subjects with Clinical Remission at Week 8 by Biologic Failure (BF) Status (As per US Definition)

Secondary: Induction Study - Number of Subjects with Endoscopic Healing at Week 8 by Biologic Failure Status

Secondary: Induction Study - Number of Subjects with Endoscopic Healing at Week 8 by Biologic Failure Status

Secondary: Induction Study - Number of Subjects with Clinical Response at Week 8 by Biologic Failure Status

Secondary: Induction Study - Number of Subjects with Clinical Response at Week 8 by Biologic Failure Status

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

Secondary: Induction Study: Number of Subjects in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)

Secondary: Induction Study - Change from Baseline in C-reactive Protein (CRP) Concentration Through Week 8

Secondary: Induction Study - Change from Baseline in C-reactive Protein (CRP) Concentration Through Week 8

Secondary: Induction Study - Number of Subjects with Normalized CRP (<=3 mg/L) up to Week 8 Among Subjects with Abnormal CRP (>3 mg/L) at Baseline

Secondary: Induction Study - Number of Subjects with Normalized CRP (<=3 mg/L) up to Week 8 Among Subjects with Abnormal CRP (>3 mg/L) at Baseline

Secondary: Induction Study - Change from Baseline in Fecal Lactoferrin Concentration Through Week 8

Secondary: Induction Study - Change from Baseline in Fecal Lactoferrin Concentration Through Week 8

Secondary: Induction Study - Number of Subjects with Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Subjects with Abnormal fecal lactoferrin (>7.24 mcg/g) at Baseline

Secondary: Induction Study - Number of Subjects with Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Subjects with Abnormal fecal lactoferrin (>7.24 mcg/g) at Baseline

Secondary: Induction Study - Change from Baseline in Fecal Calprotectin Concentration Through Week 8

Secondary: Induction Study - Change from Baseline in Fecal Calprotectin Concentration Through Week 8

Secondary: Induction Study - Number of Subjects with Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Subjects with Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline

Secondary: Induction Study - Number of Subjects with Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Subjects with Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline

Clinical Trial Results:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter study to Evaluate the Safety and Efficacy of Ustekinumab Induction and MaintenanceTherapy in Subjects with Moderately to Severely Active Ulcerative Colitis