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A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01369355
Collaborator
(none)
1,282
Enrollment
220
Locations
6
Arms
96.6
Actual Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo SC
  • Drug: Placebo IV
  • Drug: Ustekinumab 90 mg SC q8w
  • Drug: Ustekinumab 130 mg IV
  • Drug: Ustekinumab 90 mg SC q12w
 Phase 3

Detailed Description

The main purpose of this study is to determine whether additional ustekinumab treatment is beneficial in patients with moderately to severely active Crohn's disease who initially had a clinical response to IV ustekinumab in one of the 2 initial induction studies (the CNTO1275CRD3001 ["UNITI-1"] or CNTO1275CRD3002 ["UNITI-2"] induction studies). The maintenance treatment will be injections in the skin (given subcutaneously, or "SC") of 90 mg ustekinumab either every 8 weeks or 12 weeks, and the effects (both the benefits and any side effects or adverse events) will be compared to SC placebo injections (otherwise identical except without ustekinumab). Patients who responded to IV ustekinumab in the UNITI-1 (NCT01369329) or UNITI-2 (NCT01369342) induction studies will be put into one of these 3 groups by chance (randomly, like rolling dice). The study will be double-blinded (so that neither patients nor study personnel know the identity of the assigned treatment). Patients who are randomized to either SC placebo or 90mg ustekinumab SC every 12 weeks who experience worsening in their Crohn's Disease symptoms (per the study loss of response criteria) will have their treatment adjusted so that they will instead start to receive 90mg ustekinumab SC every 8 weeks. All patients from the UNITI-1 or UNITI-2 studies (in addition to the patients described above who responded to IV ustekinumab) will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. Patients who are not in clinical response to IV placebo or ustekinumab in UNITI-1 or UNITI-2 will receive both IV and SC study agent at the first visit of this study (week 0). Patients previously receiving IV placebo will receive ustekinumab 130 mg IV at week 0 (and SC placebo), and patients previously receiving IV ustekinumab will receive 90 mg ustekinumab SC at week 0 (as well as IV placebo). If these patients are in clinical response 8 weeks later, they will receive 90 SC ustekinumab at that week8 visit, and will continue to receive Ustekinumab (every 8 weeks for participants not in response to IV Ustekinumab and every 12 weeks for participants not in response to IV Placebo) throughout the rest of the study (provided they otherwise remain eligible). Patients in clinical response to IV placebo induction dosing will continue to receive SC placebo. The main part of this study, also called the maintenance portion, will last 44 weeks. After week 44, all participants who are continuing to do well will be eligible to continue to receive study agent in the second part of the study, a long term extension where the study agent will continue to be administered up to week 252. Participants who discontinue study agent, either during the study, or after week 252, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent.

Patients in response to IV ustekinumab will be randomized to receive either placebo (Group 1), Ustekinumab 90 mg SC every 12 weeks (Group 2), or Ustekinumab 90mgSC every 8 weeks (Group 3). If patients in Groups 1 or 2 lose response, they will cross over to receive ustekinumab 90mg every 8 weeks. Other populations (nonresponders to prior IV ustekinumab or IV placebo) will receive ustekinumab at Week0 (either 90mg SC or 130mg IV, respectively) and continue SC ustekinumab if in response at Week 8, Placebo IV responders will continue to receive Placebo SC q4w.

Study Design

Study Type:
Interventional
Actual Enrollment :
1282 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
Actual Study Start Date :
Sep 13, 2011
Actual Primary Completion Date :
Jun 10, 2015
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 001

Participants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w).

Drug: Placebo SC
Placebo will be administered subcutaneously.
Experimental: 002

Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w).

Drug: Ustekinumab 90 mg SC q12w
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Experimental: 003

Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w).

Drug: Ustekinumab 90 mg SC q8w
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
Experimental: 004

Participants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w.

Drug: Placebo IV
Placebo will be administered as a single Intravenous infusion at week 0.

Drug: Ustekinumab 90 mg SC q8w
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
Experimental: 005

Participants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w.

Drug: Placebo SC
Placebo will be administered subcutaneously.

Drug: Ustekinumab 130 mg IV
Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

Drug: Ustekinumab 90 mg SC q12w
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Placebo Comparator: 006

Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w.

Drug: Placebo SC
Placebo will be administered subcutaneously.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Clinical Remission at Week 44 [Week 44]

    Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.

Secondary Outcome Measures

  1. Number of Participants With Clinical Response at Week 44 [Week 44]

    Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.

  2. Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study [Week 44]

    Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.

  3. Number of Participants With Corticosteroid-free Remission at Week 44 [Week 44]

    Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.

  4. Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy [Week 44]

    Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who received study agent at the start of study CNTO1275CRD3001 or
CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:

  • Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002

  • Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002

  • Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tucson Arizona United States
2 La Jolla California United States
3 Los Angeles California United States
4 San Carlos California United States
5 San Diego California United States
6 Santa Monica California United States
7 Lone Tree Colorado United States
8 New Haven Connecticut United States
9 Boca Raton Florida United States
10 Gainesville Florida United States
11 Jacksonville Florida United States
12 Naples Florida United States
13 Weston Florida United States
14 Winter Park Florida United States
15 Atlanta Georgia United States
16 Decatur Georgia United States
17 Macon Georgia United States
18 Idaho Falls Idaho United States
19 Chicago Illinois United States
20 Evanston Illinois United States
21 Clive Iowa United States
22 Pratt Kansas United States
23 Crestview Hills Kentucky United States
24 Lexington Kentucky United States
25 Louisville Kentucky United States
26 Baton Rouge Louisiana United States
27 New Orleans Louisiana United States
28 Baltimore Maryland United States
29 Chevy Chase Maryland United States
30 Towson Maryland United States
31 Boston Massachusetts United States
32 Worcester Massachusetts United States
33 Ann Arbor Michigan United States
34 Chesterfield Michigan United States
35 Detroit Michigan United States
36 Troy Michigan United States
37 Ypsilanti Michigan United States
38 Rochester Minnesota United States
39 Jackson Mississippi United States
40 Ocean Springs Mississippi United States
41 Columbia Missouri United States
42 Lee's Summit Missouri United States
43 Urbana Missouri United States
44 Las Vegas Nevada United States
45 Lebanon New Hampshire United States
46 Marlton New Jersey United States
47 Great Neck New York United States
48 New York New York United States
49 Poughkeepsie New York United States
50 Rochester New York United States
51 Chapel Hill North Carolina United States
52 Charlotte North Carolina United States
53 Raleigh North Carolina United States
54 Cincinnati Ohio United States
55 Cleveland Ohio United States
56 Columbus Ohio United States
57 Mentor Ohio United States
58 Oklahoma City Oklahoma United States
59 Bend Oregon United States
60 Portland Oregon United States
61 Hershey Pennsylvania United States
62 Philadelphia Pennsylvania United States
63 Pittsburgh Pennsylvania United States
64 Charleston South Carolina United States
65 Columbia South Carolina United States
66 North Charleston South Carolina United States
67 Nashville Tennessee United States
68 Austin Texas United States
69 Grapevine Texas United States
70 Houston Texas United States
71 Tyler Texas United States
72 Salt Lake City Utah United States
73 Charlottesville Virginia United States
74 Chesapeake Virginia United States
75 Virginia Beach Virginia United States
76 Seattle Washington United States
77 Madison Wisconsin United States
78 Adelaide Australia
79 Bedford Park Australia
80 Box Hill Australia
81 Central Queensland M C Australia
82 Concord Australia
83 Garran Australia
84 Liverpool Australia
85 Malvern Australia
86 Parkville Australia
87 Innsbruck Austria
88 Wien Austria
89 Brussel Belgium
90 Leuven Belgium
91 Liege Belgium
92 Goiânia Brazil
93 Porto Alegre Brazil
94 Rio de Janeiro Brazil
95 São Paulo Brazil
96 Pleven Bulgaria
97 Rousse Bulgaria
98 Sofia Bulgaria
99 Varna Bulgaria
100 Calgary Alberta Canada
101 Edmonton Alberta Canada
102 Vancouver British Columbia Canada
103 Brandon Manitoba Canada
104 Hamilton Ontario Canada
105 Kingston Ontario Canada
106 London Ontario Canada
107 Toronto Ontario Canada
108 Montreal Quebec Canada
109 Saskatoon Saskatchewan Canada
110 Winnipeg Canada
111 Rijeka Croatia
112 Zagreb Croatia
113 Hradec Kralove Czechia
114 Usti nad Labem Czechia
115 Herlev Denmark
116 Silkeborg Denmark
117 Lille France
118 Marseille France
119 Paris France
120 Pessac France
121 Reims France
122 Rouen France
123 Toulouse France
124 Vandoeuvre les Nancy France
125 Berlin Germany
126 Erlangen Germany
127 Frankfurt Germany
128 Freiburg Germany
129 Halle Germany
130 Hamburg Germany
131 Hannover Germany
132 Haßloch Germany
133 Heidelberg Germany
134 Jena Germany
135 Kiel Germany
136 LÿNEBURG Germany
137 Mannheim Germany
138 München Germany
139 Münster Germany
140 Regensburg Germany
141 Stade Germany
142 Ulm Germany
143 Budapest Hungary
144 Békéscsaba Hungary
145 Debrecen Hungary
146 Mosonmagyarovar Hungary
147 Pecs Hungary
148 Szekesfehervar Hungary
149 Szeksz Rd N/a Hungary
150 Reykjavik Iceland
151 Dublin 9 Ireland
152 Jerusalem Israel
153 Kfar Saba Israel
154 Petah Tikva Israel
155 Ramat-Gan Israel
156 Rehovot Israel
157 Tel Aviv Israel
158 Zerifin Israel
159 Chikushino Japan
160 Fukuoka Japan
161 Hachioji Japan
162 Hamamatsu Japan
163 Hirosaki Japan
164 Hiroshima Japan
165 Kagoshima Japan
166 Nishinomiya Japan
167 Ohtsu Japan
168 Oita Japan
169 Osaka Japan
170 Sakura Japan
171 Sapporo Japan
172 Sendai Japan
173 Suita-shi Japan
174 Tokyo Japan
175 Tsu Japan
176 Uruma Japan
177 Yokkaichi Japan
178 Yokohama Japan
179 Yokosuka Japan
180 Daegu Korea, Republic of
181 Gyeonggi-Do Korea, Republic of
182 Seoul Korea, Republic of
183 Amsterdam Netherlands
184 Maastricht Netherlands
185 Rotterdam Netherlands
186 Auckland New Zealand
187 Christchurch New Zealand
188 Dunedin New Zealand
189 Grafton New Zealand
190 Hamilton New Zealand
191 Hastings New Zealand
192 Plenty New Zealand
193 Elblag Poland
194 Krakow Poland
195 Lodz Poland
196 Warszawa Poland
197 Moscow Russian Federation
198 Novosibirsk Russian Federation
199 Saint-Petersburg Russian Federation
200 Belgrade Serbia
201 Cape Town Western Cape South Africa
202 Cape Town South Africa
203 Pretoria South Africa
204 Somerset West South Africa
205 Madrid Spain
206 Birmingham United Kingdom
207 Brighton United Kingdom
208 Bristol United Kingdom
209 Cambridge United Kingdom
210 Cardiff United Kingdom
211 Exeter United Kingdom
212 Gloucester United Kingdom
213 Liverpool United Kingdom
214 London United Kingdom
215 Manchester United Kingdom
216 Norwich United Kingdom
217 Nottinghamshirecc United Kingdom
218 Oxford United Kingdom
219 Shropshire United Kingdom
220 Southampton United Kingdom

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01369355
Other Study ID Numbers:
  • CR018421
  • CNTO1275CRD3003
  • 2010-022760-12
First Posted:
Jun 8, 2011
Last Update Posted:
Oct 22, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
Ustekinumab
Stelara, Moderately to severely active Crohn's Disease
IBD, Crohn's
UNITI
colitis
IL-12
IL-23
Additional relevant MeSH terms:
Crohn Disease
Colitis
Inflammatory Bowel Diseases
Ustekinumab

Study Results

Participant Flow

Recruitment Details Out of 1282 participants enrolled,1 was excluded from study before assignment to arm/group due to deviation from Good Clinical Practice at 1 study site. Hence 1281 participants were analyzed. Total 397 participants who were in clinical response to ustekinumab induction were randomized in maintenance study and considered as primary population.
Pre-assignment Detail Due to a stability issue with the batch of Intravenous (IV) drug (130 mg ustekinumab), in November 2011 sponsor temporarily suspended dosing in induction studies (CRD3001 and CRD3002) and this maintenance study (CRD3003). All 3 studies were restarted with a 90 milligram per milliliter (mg/mL) formulation for IV administration on 17 February 2012.
Arm/Group Title Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance Placebo (PBO)-I-Rsp - PBO Maintenance PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study. Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized. Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized. Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized. Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272). Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272). Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
Period Title: Week 0 - Week 44 (Maintenance)
STARTED 133 132 132 123 285 476 0 0 0
COMPLETED 102 103 101 93 131 204 0 0 0
NOT COMPLETED 31 29 31 30 154 272 0 0 0
Period Title: Week 0 - Week 44 (Maintenance)
STARTED 0 0 0 0 0 0 151 213 354
COMPLETED 0 0 0 0 0 0 0 107 183
NOT COMPLETED 0 0 0 0 0 0 151 106 171

Baseline Characteristics

Arm/Group Title Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance Placebo (PBO)-I-Rsp - PBO Maintenance PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance Total
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study. Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized. Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized. Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized. Total of all reporting groups
Overall Participants 133 132 132 123 285 476 1281
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
39.5
(12.69)
38.6
(13.65)
37.9
(13.2)
39.1
(12.46)
39
(12.33)
37.4
(12.5)
38.3
(12.68)
Sex: Female, Male (Count of Participants)
Female
74
55.6%
74
56.1%
76
57.6%
64
52%
149
52.3%
275
57.8%
712
55.6%
Male
59
44.4%
58
43.9%
56
42.4%
59
48%
136
47.7%
201
42.2%
569
44.4%
Region of Enrollment (Count of Participants)
Australia
4
3%
2
1.5%
3
2.3%
4
3.3%
10
3.5%
15
3.2%
38
3%
Austria
1
0.8%
3
2.3%
1
0.8%
0
0%
0
0%
1
0.2%
6
0.5%
Belgium
2
1.5%
4
3%
1
0.8%
1
0.8%
7
2.5%
16
3.4%
31
2.4%
Bulgaria
5
3.8%
2
1.5%
2
1.5%
4
3.3%
1
0.4%
7
1.5%
21
1.6%
Brazil
1
0.8%
1
0.8%
3
2.3%
2
1.6%
2
0.7%
3
0.6%
12
0.9%
Canada
10
7.5%
4
3%
12
9.1%
5
4.1%
17
6%
44
9.2%
92
7.2%
Denmark
1
0.8%
2
1.5%
1
0.8%
0
0%
0
0%
0
0%
4
0.3%
Spain
1
0.8%
0
0%
1
0.8%
0
0%
0
0%
1
0.2%
3
0.2%
France
6
4.5%
8
6.1%
9
6.8%
1
0.8%
13
4.6%
27
5.7%
64
5%
United Kingdom
4
3%
7
5.3%
5
3.8%
7
5.7%
15
5.3%
29
6.1%
67
5.2%
Croatia
1
0.8%
1
0.8%
0
0%
1
0.8%
0
0%
1
0.2%
4
0.3%
Hungary
11
8.3%
8
6.1%
8
6.1%
10
8.1%
14
4.9%
13
2.7%
64
5%
Ireland
0
0%
0
0%
1
0.8%
0
0%
0
0%
0
0%
1
0.1%
Iceland
1
0.8%
1
0.8%
0
0%
0
0%
0
0%
0
0%
2
0.2%
Israel
3
2.3%
1
0.8%
0
0%
1
0.8%
2
0.7%
8
1.7%
15
1.2%
Italy
6
4.5%
2
1.5%
2
1.5%
1
0.8%
4
1.4%
8
1.7%
23
1.8%
Japan
4
3%
8
6.1%
9
6.8%
4
3.3%
18
6.3%
31
6.5%
74
5.8%
Korea, Democratic People'S Republic Of
3
2.3%
3
2.3%
2
1.5%
2
1.6%
5
1.8%
7
1.5%
22
1.7%
Netherlands
4
3%
4
3%
4
3%
1
0.8%
9
3.2%
14
2.9%
36
2.8%
New Zealand
3
2.3%
5
3.8%
2
1.5%
1
0.8%
1
0.4%
3
0.6%
15
1.2%
Poland
3
2.3%
5
3.8%
6
4.5%
6
4.9%
6
2.1%
10
2.1%
36
2.8%
Russia
2
1.5%
2
1.5%
3
2.3%
5
4.1%
1
0.4%
4
0.8%
17
1.3%
Serbia
2
1.5%
7
5.3%
4
3%
3
2.4%
2
0.7%
1
0.2%
19
1.5%
United States
41
30.8%
42
31.8%
40
30.3%
50
40.7%
124
43.5%
198
41.6%
495
38.6%
South Africa
5
3.8%
2
1.5%
5
3.8%
7
5.7%
5
1.8%
7
1.5%
31
2.4%
Czech Republic
0
0%
0
0%
1
0.8%
0
0%
2
0.7%
2
0.4%
5
0.4%
Germany
9
6.8%
8
6.1%
7
5.3%
7
5.7%
27
9.5%
26
5.5%
84
6.6%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Clinical Remission at Week 44
Description Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 44

Outcome Measure Data

Analysis Population Description
The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Arm/Group Title Placebo Subcutaneously (SC) Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) Ustekinumab 90 mg SC q8w
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
Measure Participants 131 129 128
Number [participants]
47
35.3%
63
47.7%
68
51.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.040
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 mg SC q8w
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
2. Secondary Outcome
Title Number of Participants With Clinical Response at Week 44
Description Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Time Frame Week 44

Outcome Measure Data

Analysis Population Description
The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Arm/Group Title Placebo Subcutaneously (SC) Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) Ustekinumab 90 mg SC q8w
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
Measure Participants 131 129 128
Number [participants]
58
43.6%
75
56.8%
76
57.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.033
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 mg SC q8w
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.018
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
3. Secondary Outcome
Title Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study
Description Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.
Time Frame Week 44

Outcome Measure Data

Analysis Population Description
Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Subcutaneously (SC) Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) Ustekinumab 90 mg SC q8w
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
Measure Participants 79 78 78
Number [participants]
36
27.1%
44
33.3%
52
39.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.189
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 mg SC q8w
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.007
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.
4. Secondary Outcome
Title Number of Participants With Corticosteroid-free Remission at Week 44
Description Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.
Time Frame Week 44

Outcome Measure Data

Analysis Population Description
The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Arm/Group Title Placebo Subcutaneously (SC) Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) Ustekinumab 90 mg SC q8w
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
Measure Participants 131 129 128
Number [participants]
39
29.3%
55
41.7%
60
45.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.035
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 mg SC q8w
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.
5. Secondary Outcome
Title Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
Description Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.
Time Frame Week 44

Outcome Measure Data

Analysis Population Description
The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Arm/Group Title Placebo Subcutaneously (SC) Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) Ustekinumab 90 mg SC q8w
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study. Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
Measure Participants 61 57 56
Number [participants]
16
12%
22
16.7%
23
17.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Subcutaneously (SC), Ustekinumab 90 mg SC q8w
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.102
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.

Adverse Events

Time Frame Up to Week 272
Adverse Event Reporting Description Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
Arm/Group Title Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST 90 mg SC Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
Arm/Group Description Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response). Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward). Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response). Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q12w and had dose adjustment to ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward). Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8w (includes events up to the time of loss of response). Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward). Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized. Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized. Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized. Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272). Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272). Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
All Cause Mortality
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST 90 mg SC Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 2/213 (0.9%) 4/354 (1.1%)
Serious Adverse Events
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST 90 mg SC Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 22/133 (16.5%) 7/51 (13.7%) 16/132 (12.1%) 5/29 (17.2%) 13/131 (9.9%) 6/29 (20.7%) 19/123 (15.4%) 47/285 (16.5%) 77/476 (16.2%) 26/151 (17.2%) 68/213 (31.9%) 99/354 (28%)
Blood and lymphatic system disorders
Anaemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Iron Deficiency Anaemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Lymphadenitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Cardiac disorders
Acute Myocardial Infarction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 2/213 (0.9%) 0/354 (0%)
Angina Pectoris 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Aortic Valve Incompetence 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Atrial Fibrillation 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Cardio-Respiratory Arrest 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Cardiomyopathy 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Coronary Artery Disease 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 2/213 (0.9%) 0/354 (0%)
Myocardial Infarction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Congenital, familial and genetic disorders
Fibrous Dysplasia of Bone 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Endocrine disorders
Adrenal Insufficiency 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Eye disorders
Chorioretinopathy 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Retinal Detachment 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Strabismus 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Gastrointestinal disorders
Abdominal Adhesions 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Abdominal Discomfort 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Abdominal Hernia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 1/29 (3.4%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Abdominal Pain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 2/151 (1.3%) 1/213 (0.5%) 5/354 (1.4%)
Abdominal Pain Lower 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Anal Fissure 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Anal Fistula 2/133 (1.5%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 2/285 (0.7%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Colitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Colon Dysplasia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Constipation 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 1/354 (0.3%)
Crohn's Disease 7/133 (5.3%) 4/51 (7.8%) 5/132 (3.8%) 3/29 (10.3%) 4/131 (3.1%) 3/29 (10.3%) 6/123 (4.9%) 15/285 (5.3%) 30/476 (6.3%) 12/151 (7.9%) 17/213 (8%) 32/354 (9%)
Cyclic Vomiting Syndrome 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Diarrhoea 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Dyspepsia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Dysphagia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Enterocutaneous Fistula 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Enterovesical Fistula 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Epiploic Appendagitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Faecaloma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 2/285 (0.7%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Fistula of Small Intestine 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Gastric Ulcer Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Gastritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Gastrointestinal Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 1/29 (3.4%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 3/213 (1.4%) 0/354 (0%)
Haematemesis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Haematochezia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 1/213 (0.5%) 0/354 (0%)
Haemorrhoidal Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Ileal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Inflammatory Bowel Disease 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Intestinal Obstruction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 1/151 (0.7%) 1/213 (0.5%) 0/354 (0%)
Intestinal Perforation 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Intestinal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 2/476 (0.4%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Large Intestinal Obstruction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Large Intestinal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 2/131 (1.5%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Large Intestine Perforation 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Large Intestine Polyp 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Lower Gastrointestinal Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Mallory-Weiss Syndrome 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Melaena 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Oesophageal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Rectal Prolapse 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Rectal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Small Intestinal Obstruction 0/133 (0%) 1/51 (2%) 1/132 (0.8%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 1/123 (0.8%) 2/285 (0.7%) 10/476 (2.1%) 4/151 (2.6%) 6/213 (2.8%) 10/354 (2.8%)
Small Intestinal Perforation 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Small Intestinal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 1/151 (0.7%) 1/213 (0.5%) 1/354 (0.3%)
Tooth Impacted 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Umbilical Hernia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
General disorders
Asthenia 0/133 (0%) 1/51 (2%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Chest Pain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Dysplasia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Incarcerated Hernia 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Non-Cardiac Chest Pain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 1/29 (3.4%) 0/123 (0%) 0/285 (0%) 2/476 (0.4%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Oedema Peripheral 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pyrexia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Sudden Death 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Hepatobiliary disorders
Bile Duct Stone 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Cholecystitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 1/29 (3.4%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 3/354 (0.8%)
Immune system disorders
Anaphylactic Reaction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Infections and infestations
Abdominal Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 1/476 (0.2%) 0/151 (0%) 2/213 (0.9%) 1/354 (0.3%)
Abdominal Infection 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Abscess Intestinal 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Acarodermatitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Acute Sinusitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Anal Abscess 1/133 (0.8%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 3/285 (1.1%) 3/476 (0.6%) 1/151 (0.7%) 6/213 (2.8%) 3/354 (0.8%)
Anal Fistula Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Appendicitis 0/133 (0%) 0/51 (0%) 2/132 (1.5%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Bacteraemia 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Bronchitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Campylobacter Gastroenteritis 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Cellulitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 2/213 (0.9%) 1/354 (0.3%)
Clostridium Difficile Colitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 1/285 (0.4%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 1/354 (0.3%)
Clostridium Difficile Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Cytomegalovirus Colitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Cytomegalovirus Viraemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Device Related Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Diverticulitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 2/354 (0.6%)
Gastroenteritis 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 1/476 (0.2%) 1/151 (0.7%) 1/213 (0.5%) 2/354 (0.6%)
Gastroenteritis Viral 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Hepatitis Infectious Mononucleosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Influenza 0/133 (0%) 1/51 (2%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Liver Abscess 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Lower Respiratory Tract Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Mastitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Myringitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Ophthalmic Herpes Zoster 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Parainfluenzae Virus Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Perirectal Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Peritonitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 1/29 (3.4%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pneumonia 2/133 (1.5%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 1/29 (3.4%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 2/213 (0.9%) 2/354 (0.6%)
Pneumonia Pneumococcal 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 1/29 (3.4%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pneumonia Staphylococcal 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Postoperative Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 1/354 (0.3%)
Postoperative Wound Infection 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pseudomembranous Colitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Pyelonephritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Rectal Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Sepsis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Septic Shock 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Sialoadenitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Tonsillitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Tubo-Ovarian Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Vaginal Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Vascular Device Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Viral Infection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Wound Abscess 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Injury, poisoning and procedural complications
Alcohol Poisoning 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Allergic Transfusion Reaction 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Anastomotic Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Anastomotic Leak 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Concussion 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Contusion 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Forearm Fracture 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Gastrointestinal Anastomotic Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Heat Stroke 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Humerus Fracture 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Intestinal Anastomosis Complication 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 1/151 (0.7%) 0/213 (0%) 1/354 (0.3%)
Ligament Rupture 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Ligament Sprain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Meniscus Injury 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Muscle Injury 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Procedural Intestinal Perforation 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Procedural Pain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Seroma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Sternal Injury 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Thoracic Vertebral Fracture 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Investigations
Blood Electrolytes Abnormal 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Electrocardiogram Abnormal 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Faecal Volume Increased 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Hepatic Enzyme Increased 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Troponin Increased 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Metabolism and nutrition disorders
Dehydration 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 2/213 (0.9%) 3/354 (0.8%)
Electrolyte Imbalance 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Hypokalaemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 1/354 (0.3%)
Hyponatraemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Malnutrition 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 2/285 (0.7%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Back Pain 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Costochondritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Dactylitis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Fibromyalgia 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Intervertebral Disc Protrusion 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Intervertebral Disc Space Narrowing 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Lumbar Spinal Stenosis 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Osteoarthritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 3/354 (0.8%)
Polyarthritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Rotator Cuff Syndrome 0/133 (0%) 0/51 (0%) 0/132 (0%) 1/29 (3.4%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Spinal Osteoarthritis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Spinal Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Chronic Myeloid Leukaemia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Endometrial Adenocarcinoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Fibroadenoma of Breast 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Lentigo Maligna 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Meningioma 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Ovarian Adenoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pancreatic Carcinoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Papillary Thyroid Cancer 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Renal Cell Carcinoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Seminoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Small Intestine Adenocarcinoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Uterine Leiomyoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Nervous system disorders
Cerebral Infarction 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Dementia with Lewy Bodies 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Headache 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Idiopathic Intracranial Hypertension 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Intracranial Aneurysm 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Ischaemic Stroke 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Migraine 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Paraesthesia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Radiculopathy 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Seizure 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Subarachnoid Haemorrhage 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Syncope 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Transient Ischaemic Attack 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Trigeminal Neuralgia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 3/213 (1.4%) 3/354 (0.8%)
Premature Delivery 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Premature Labour 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Psychiatric disorders
Depression 0/133 (0%) 1/51 (2%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 1/476 (0.2%) 1/151 (0.7%) 0/213 (0%) 0/354 (0%)
Hallucination 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Suicidal Ideation 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Suicide Attempt 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Renal and urinary disorders
Acute Kidney Injury 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
End Stage Renal Disease 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Nephrolithiasis 0/133 (0%) 1/51 (2%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 1/151 (0.7%) 2/213 (0.9%) 1/354 (0.3%)
Renal Colic 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Renal Tubular Necrosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Ureterolithiasis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Urinary Retention 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Reproductive system and breast disorders
Adenomyosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Bartholin's Cyst 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Female Genital Tract Fistula 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Menorrhagia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Pelvic Congestion 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Uterine Prolapse 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 1/476 (0.2%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Respiratory, thoracic and mediastinal disorders
Asphyxia 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Chronic Obstructive Pulmonary Disease 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Nasal Polyps 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Pulmonary Embolism 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 1/151 (0.7%) 1/213 (0.5%) 0/354 (0%)
Pulmonary Granuloma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Pulmonary Haematoma 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Skin and subcutaneous tissue disorders
Pustular Psoriasis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Stevens-Johnson Syndrome 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Social circumstances
Breast Prosthesis User 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Miscarriage of Partner 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 1/123 (0.8%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Substance Abuser 1/133 (0.8%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Surgical and medical procedures
Abdominal Hernia Repair 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Ileostomy Closure 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Knee Arthroplasty 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Pelvic Pouch Procedure 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Rotator Cuff Repair 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Vascular disorders
Aortic Aneurysm 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Aortic Dissection 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Aortic Stenosis 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 1/354 (0.3%)
Deep Vein Thrombosis 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 1/285 (0.4%) 2/476 (0.4%) 0/151 (0%) 0/213 (0%) 2/354 (0.6%)
Essential Hypertension 0/133 (0%) 0/51 (0%) 1/132 (0.8%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 0/213 (0%) 0/354 (0%)
Hypertension 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 1/354 (0.3%)
Hypertensive Urgency 0/133 (0%) 0/51 (0%) 0/132 (0%) 0/29 (0%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 0/285 (0%) 0/476 (0%) 0/151 (0%) 1/213 (0.5%) 0/354 (0%)
Other (Not Including Serious) Adverse Events
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST 90 mg SC Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 94/133 (70.7%) 34/51 (66.7%) 88/132 (66.7%) 20/29 (69%) 84/131 (64.1%) 18/29 (62.1%) 82/123 (66.7%) 160/285 (56.1%) 275/476 (57.8%) 83/151 (55%) 162/213 (76.1%) 293/354 (82.8%)
Blood and lymphatic system disorders
Anaemia 0/133 (0%) 0/51 (0%) 5/132 (3.8%) 1/29 (3.4%) 3/131 (2.3%) 0/29 (0%) 5/123 (4.1%) 6/285 (2.1%) 11/476 (2.3%) 2/151 (1.3%) 15/213 (7%) 17/354 (4.8%)
Gastrointestinal disorders
Abdominal Pain 17/133 (12.8%) 3/51 (5.9%) 12/132 (9.1%) 5/29 (17.2%) 11/131 (8.4%) 1/29 (3.4%) 15/123 (12.2%) 23/285 (8.1%) 38/476 (8%) 16/151 (10.6%) 38/213 (17.8%) 68/354 (19.2%)
Abdominal Pain Upper 3/133 (2.3%) 1/51 (2%) 4/132 (3%) 1/29 (3.4%) 2/131 (1.5%) 2/29 (6.9%) 5/123 (4.1%) 8/285 (2.8%) 15/476 (3.2%) 8/151 (5.3%) 11/213 (5.2%) 22/354 (6.2%)
Constipation 4/133 (3%) 1/51 (2%) 6/132 (4.5%) 2/29 (6.9%) 3/131 (2.3%) 0/29 (0%) 0/123 (0%) 6/285 (2.1%) 10/476 (2.1%) 0/151 (0%) 9/213 (4.2%) 22/354 (6.2%)
Crohn's Disease 12/133 (9%) 5/51 (9.8%) 12/132 (9.1%) 3/29 (10.3%) 12/131 (9.2%) 2/29 (6.9%) 13/123 (10.6%) 17/285 (6%) 40/476 (8.4%) 25/151 (16.6%) 44/213 (20.7%) 80/354 (22.6%)
Diarrhoea 7/133 (5.3%) 2/51 (3.9%) 11/132 (8.3%) 1/29 (3.4%) 5/131 (3.8%) 0/29 (0%) 11/123 (8.9%) 10/285 (3.5%) 12/476 (2.5%) 11/151 (7.3%) 30/213 (14.1%) 50/354 (14.1%)
Gastrooesophageal Reflux Disease 2/133 (1.5%) 2/51 (3.9%) 1/132 (0.8%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 2/123 (1.6%) 4/285 (1.4%) 7/476 (1.5%) 2/151 (1.3%) 11/213 (5.2%) 15/354 (4.2%)
Nausea 9/133 (6.8%) 3/51 (5.9%) 10/132 (7.6%) 3/29 (10.3%) 4/131 (3.1%) 1/29 (3.4%) 12/123 (9.8%) 15/285 (5.3%) 46/476 (9.7%) 12/151 (7.9%) 23/213 (10.8%) 34/354 (9.6%)
Vomiting 9/133 (6.8%) 3/51 (5.9%) 5/132 (3.8%) 2/29 (6.9%) 4/131 (3.1%) 2/29 (6.9%) 5/123 (4.1%) 6/285 (2.1%) 33/476 (6.9%) 2/151 (1.3%) 14/213 (6.6%) 26/354 (7.3%)
General disorders
Fatigue 6/133 (4.5%) 2/51 (3.9%) 8/132 (6.1%) 1/29 (3.4%) 6/131 (4.6%) 0/29 (0%) 9/123 (7.3%) 11/285 (3.9%) 15/476 (3.2%) 8/151 (5.3%) 13/213 (6.1%) 29/354 (8.2%)
Injection Site Erythema 0/133 (0%) 1/51 (2%) 1/132 (0.8%) 1/29 (3.4%) 7/131 (5.3%) 1/29 (3.4%) 2/123 (1.6%) 5/285 (1.8%) 7/476 (1.5%) 1/151 (0.7%) 7/213 (3.3%) 7/354 (2%)
Pyrexia 11/133 (8.3%) 2/51 (3.9%) 11/132 (8.3%) 3/29 (10.3%) 9/131 (6.9%) 1/29 (3.4%) 12/123 (9.8%) 16/285 (5.6%) 25/476 (5.3%) 9/151 (6%) 19/213 (8.9%) 19/354 (5.4%)
Infections and infestations
Bronchitis 4/133 (3%) 3/51 (5.9%) 1/132 (0.8%) 0/29 (0%) 6/131 (4.6%) 0/29 (0%) 3/123 (2.4%) 5/285 (1.8%) 7/476 (1.5%) 4/151 (2.6%) 13/213 (6.1%) 30/354 (8.5%)
Gastroenteritis 5/133 (3.8%) 1/51 (2%) 3/132 (2.3%) 0/29 (0%) 4/131 (3.1%) 0/29 (0%) 4/123 (3.3%) 8/285 (2.8%) 18/476 (3.8%) 7/151 (4.6%) 21/213 (9.9%) 41/354 (11.6%)
Gastroenteritis Viral 1/133 (0.8%) 3/51 (5.9%) 4/132 (3%) 0/29 (0%) 4/131 (3.1%) 2/29 (6.9%) 5/123 (4.1%) 6/285 (2.1%) 6/476 (1.3%) 2/151 (1.3%) 11/213 (5.2%) 12/354 (3.4%)
Influenza 4/133 (3%) 1/51 (2%) 8/132 (6.1%) 1/29 (3.4%) 5/131 (3.8%) 1/29 (3.4%) 4/123 (3.3%) 9/285 (3.2%) 8/476 (1.7%) 4/151 (2.6%) 25/213 (11.7%) 37/354 (10.5%)
Nasopharyngitis 10/133 (7.5%) 4/51 (7.8%) 17/132 (12.9%) 4/29 (13.8%) 14/131 (10.7%) 0/29 (0%) 15/123 (12.2%) 32/285 (11.2%) 52/476 (10.9%) 16/151 (10.6%) 54/213 (25.4%) 100/354 (28.2%)
Pharyngitis Streptococcal 2/133 (1.5%) 0/51 (0%) 0/132 (0%) 1/29 (3.4%) 0/131 (0%) 2/29 (6.9%) 2/123 (1.6%) 3/285 (1.1%) 1/476 (0.2%) 0/151 (0%) 2/213 (0.9%) 3/354 (0.8%)
Sinusitis 2/133 (1.5%) 0/51 (0%) 6/132 (4.5%) 2/29 (6.9%) 4/131 (3.1%) 2/29 (6.9%) 5/123 (4.1%) 12/285 (4.2%) 17/476 (3.6%) 8/151 (5.3%) 19/213 (8.9%) 36/354 (10.2%)
Upper Respiratory Tract Infection 21/133 (15.8%) 1/51 (2%) 9/132 (6.8%) 0/29 (0%) 13/131 (9.9%) 1/29 (3.4%) 7/123 (5.7%) 25/285 (8.8%) 33/476 (6.9%) 14/151 (9.3%) 40/213 (18.8%) 62/354 (17.5%)
Urinary Tract Infection 3/133 (2.3%) 1/51 (2%) 9/132 (6.8%) 1/29 (3.4%) 4/131 (3.1%) 1/29 (3.4%) 7/123 (5.7%) 5/285 (1.8%) 17/476 (3.6%) 7/151 (4.6%) 15/213 (7%) 35/354 (9.9%)
Injury, poisoning and procedural complications
Contusion 1/133 (0.8%) 1/51 (2%) 1/132 (0.8%) 2/29 (6.9%) 1/131 (0.8%) 0/29 (0%) 2/123 (1.6%) 1/285 (0.4%) 5/476 (1.1%) 5/151 (3.3%) 5/213 (2.3%) 5/354 (1.4%)
Musculoskeletal and connective tissue disorders
Arthralgia 18/133 (13.5%) 6/51 (11.8%) 22/132 (16.7%) 5/29 (17.2%) 18/131 (13.7%) 3/29 (10.3%) 23/123 (18.7%) 29/285 (10.2%) 49/476 (10.3%) 11/151 (7.3%) 27/213 (12.7%) 40/354 (11.3%)
Arthritis 3/133 (2.3%) 0/51 (0%) 3/132 (2.3%) 0/29 (0%) 1/131 (0.8%) 0/29 (0%) 8/123 (6.5%) 7/285 (2.5%) 3/476 (0.6%) 1/151 (0.7%) 1/213 (0.5%) 4/354 (1.1%)
Back Pain 6/133 (4.5%) 2/51 (3.9%) 5/132 (3.8%) 1/29 (3.4%) 6/131 (4.6%) 3/29 (10.3%) 2/123 (1.6%) 12/285 (4.2%) 15/476 (3.2%) 13/151 (8.6%) 18/213 (8.5%) 48/354 (13.6%)
Pain in Extremity 0/133 (0%) 1/51 (2%) 0/132 (0%) 1/29 (3.4%) 5/131 (3.8%) 1/29 (3.4%) 0/123 (0%) 4/285 (1.4%) 6/476 (1.3%) 1/151 (0.7%) 9/213 (4.2%) 18/354 (5.1%)
Nervous system disorders
Headache 15/133 (11.3%) 6/51 (11.8%) 15/132 (11.4%) 2/29 (6.9%) 15/131 (11.5%) 2/29 (6.9%) 16/123 (13%) 21/285 (7.4%) 41/476 (8.6%) 12/151 (7.9%) 19/213 (8.9%) 40/354 (11.3%)
Psychiatric disorders
Anxiety 1/133 (0.8%) 1/51 (2%) 2/132 (1.5%) 2/29 (6.9%) 0/131 (0%) 0/29 (0%) 0/123 (0%) 4/285 (1.4%) 3/476 (0.6%) 1/151 (0.7%) 6/213 (2.8%) 12/354 (3.4%)
Respiratory, thoracic and mediastinal disorders
Cough 3/133 (2.3%) 1/51 (2%) 4/132 (3%) 0/29 (0%) 7/131 (5.3%) 0/29 (0%) 6/123 (4.9%) 9/285 (3.2%) 26/476 (5.5%) 8/151 (5.3%) 13/213 (6.1%) 24/354 (6.8%)
Oropharyngeal Pain 4/133 (3%) 2/51 (3.9%) 2/132 (1.5%) 2/29 (6.9%) 3/131 (2.3%) 1/29 (3.4%) 2/123 (1.6%) 8/285 (2.8%) 13/476 (2.7%) 0/151 (0%) 10/213 (4.7%) 12/354 (3.4%)
Skin and subcutaneous tissue disorders
Acne 1/133 (0.8%) 3/51 (5.9%) 1/132 (0.8%) 0/29 (0%) 2/131 (1.5%) 1/29 (3.4%) 0/123 (0%) 5/285 (1.8%) 7/476 (1.5%) 2/151 (1.3%) 6/213 (2.8%) 9/354 (2.5%)
Rash 5/133 (3.8%) 2/51 (3.9%) 4/132 (3%) 1/29 (3.4%) 7/131 (5.3%) 2/29 (6.9%) 5/123 (4.1%) 5/285 (1.8%) 22/476 (4.6%) 5/151 (3.3%) 12/213 (5.6%) 20/354 (5.6%)
Urticaria 1/133 (0.8%) 0/51 (0%) 2/132 (1.5%) 0/29 (0%) 0/131 (0%) 2/29 (6.9%) 2/123 (1.6%) 2/285 (0.7%) 3/476 (0.6%) 0/151 (0%) 1/213 (0.5%) 2/354 (0.6%)

Limitations/Caveats

The global study was interrupted due to issues with the clinical supply.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

Name/Title Vice President
Organization Janssen Research & Development, LLC
Phone 844-434-4210
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01369355
Other Study ID Numbers:
  • CR018421
  • CNTO1275CRD3003
  • 2010-022760-12
First Posted:
Jun 8, 2011
Last Update Posted:
Oct 22, 2020
Last Verified:
Sep 1, 2020