An Efficacy and Safety Study of Golimumab (CNTO 148) in P... | NCT00488631 | Trialant
NCT00488631
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Apr 26, 2016Estimated
Enrollment
1,228Actual
Phase
Phase 3
Conditions
Colitis, Ulcerative
Interventions
Placebo
Golimumab 50 mg
Golimumab 100 mg
Golimumab 200 mg
Countries
United States
Australia
Austria
Belgium
Bulgaria
Canada
Czechia
Denmark
France
Germany
Hungary
India
Israel
Japan
Latvia
Lithuania
Netherlands
New Zealand
Poland
Romania
Russia
Serbia
Slovakia
South Africa
Sweden
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00488631
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR014179
Secondary IDs
ID
Type
Description
Link
2006-003399-37
EudraCT Number
C0524T18
Other Identifier
Janssen Research & Development, LLC
Brief Title
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Mar 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2007
Primary Completion Date
Oct 2011Actual
Completion Date
Feb 2015Actual
First Submitted Date
Jun 18, 2007
First Submission Date that Met QC Criteria
Jun 18, 2007
First Posted Date
Jun 20, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2013
Results First Submitted that Met QC Criteria
Oct 14, 2013
Results First Posted Date
Nov 11, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 12, 2012
Certification/Extension First Submitted that Passed QC Review
Mar 12, 2012
Certification/Extension First Posted Date
Mar 14, 2012Estimated
Last Update Submitted Date
Mar 24, 2016
Last Update Posted Date
Apr 26, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Detailed Description
This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
Biological: Placebo
Biological: Golimumab 100 mg
GLM-I-Rsp-Golimumab 50 mg Maintenance
Experimental
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg
GLM-I-Rsp-Golimumab 100 mg Maintenance
Experimental
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52.
Biological: Golimumab 100 mg
Biological: Golimumab 200 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Biological
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants in Clinical Response Through Week 54
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Induction Baseline, Week 0 through Week 54
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Clinical Remission at Both Week 30 and Week 54
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Exclusion Criteria:
Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Weinstein CLJ, Meehan AG, Govoni M, Lin J, Reinisch W. Low Occurrence of Colectomy With Long-Term (up to 4 Years) Golimumab Treatment in Patients With Moderate-to-Severe Active Ulcerative Colitis: Data From the PURSUIT Maintenance and Long-Term Extension Studies. Crohns Colitis 360. 2023 Aug 26;5(3):otad044. doi: 10.1093/crocol/otad044. eCollection 2023 Jul.
Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
Biological: Placebo
Biological: Golimumab 100 mg
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Experimental
Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Biological: Golimumab 100 mg
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Experimental
Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
GLM-I-Rsp-Golimumab 50 mg Maintenance
Golimumab 100 mg
Biological
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 100 mg Maintenance
Week 30 and Week 54
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
Week 30 and Week 54
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Week 30 and Week 54
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Week 54
Little Rock
Arkansas
United States
Anaheim
California
United States
Merced
California
United States
Orange
California
United States
Roseville
California
United States
San Diego
California
United States
Lakewood
Colorado
United States
Littleton
Colorado
United States
Bristol
Connecticut
United States
Newark
Delaware
United States
Boca Raton
Florida
United States
Gainesville
Florida
United States
Hialeah
Florida
United States
Hollywood
Florida
United States
Jacksonville
Florida
United States
Naples
Florida
United States
New Port Richey
Florida
United States
North Miami Beach
Florida
United States
Port Orange
Florida
United States
Tampa
Florida
United States
Winter Park
Florida
United States
Zephyrhills
Florida
United States
Atlanta
Georgia
United States
Decatur
Georgia
United States
Savannah
Georgia
United States
Snellville
Georgia
United States
Arlington Heights
Illinois
United States
Chicago
Illinois
United States
Clive
Iowa
United States
Fort Dodge
Iowa
United States
Pratt
Kansas
United States
Topeka
Kansas
United States
Lexington
Kentucky
United States
Louisville
Kentucky
United States
Monroe
Louisiana
United States
Hagerstown
Maryland
United States
Hollywood
Maryland
United States
Laurel
Maryland
United States
Worcester
Massachusetts
United States
Ann Arbor
Michigan
United States
Dearborn
Michigan
United States
Troy
Michigan
United States
Plymouth
Minnesota
United States
Rochester
Minnesota
United States
Pascagoula
Mississippi
United States
Tupelo
Mississippi
United States
Urbana
Missouri
United States
Las Vegas
Nevada
United States
Lebanon
New Hampshire
United States
Egg Harbor
New Jersey
United States
Great Neck
New York
United States
Huntington
New York
United States
New York
New York
United States
Rochester
New York
United States
Asheville
North Carolina
United States
Boone
North Carolina
United States
Charlotte
North Carolina
United States
Harrisburg
North Carolina
United States
Kinston
North Carolina
United States
Morganton
North Carolina
United States
New Bern
North Carolina
United States
Raleigh
North Carolina
United States
Wilmington
North Carolina
United States
Winston-Salem
North Carolina
United States
Fargo
North Dakota
United States
Cincinnati
Ohio
United States
Cleveland
Ohio
United States
Colombus
Ohio
United States
Norman
Oklahoma
United States
Oklahoma City
Oklahoma
United States
Tulsa
Oklahoma
United States
Portland
Oregon
United States
Limerick
Pennsylvania
United States
Philadelphia
Pennsylvania
United States
Charleston
South Carolina
United States
Columbia
South Carolina
United States
Germantown
Tennessee
United States
Nashville
Tennessee
United States
Austin
Texas
United States
Dallas
Texas
United States
Galveston
Texas
United States
Houston
Texas
United States
Logan
Utah
United States
Ogden
Utah
United States
Burlington
Vermont
United States
Chesapeake
Virginia
United States
Christiansburg
Virginia
United States
Fairfax
Virginia
United States
Richmond
Virginia
United States
Bellevue
Washington
United States
Seattle
Washington
United States
Spokane
Washington
United States
Tacoma
Washington
United States
Madison
Wisconsin
United States
Milwaukee
Wisconsin
United States
Adelaide
Australia
Bankstown
Australia
Box Hill
Australia
Brisbane
Australia
Cairns
Australia
Fitzroy
Australia
Fremantle
Australia
Herston
Australia
Launceston
Australia
Malvern
Australia
Parkville
Australia
Prahran
Australia
Westmead
Australia
Innsbruck
Austria
Vienna
Austria
Bonheiden
Belgium
Brussels
Belgium
Ghent
Belgium
Leuven
Belgium
Liège
Belgium
Roeselare
Belgium
Bulgaria
Bulgaria
Pleven
Bulgaria
Plovdiv
Bulgaria
Rousse
Bulgaria
Sofia
Bulgaria
Calgary
Alberta
Canada
Vancouver
British Columbia
Canada
Victoria
British Columbia
Canada
Winnipeg
Manitoba
Canada
Barrie
Ontario
Canada
Chatham
Ontario
Canada
Hamilton
Ontario
Canada
Kingston
Ontario
Canada
London
Ontario
Canada
Vaughan
Ontario
Canada
Montreal
Quebec
Canada
Québec
Quebec
Canada
Saskatoon
Saskatchewan
Canada
Toronto
Canada
Windsor
Canada
Èeské Budìjovice 1
Czechia
Hradec Králové
Czechia
Litoměřice
Czechia
Ostrava
Czechia
Aalborg
Denmark
Aarhus C
Denmark
Hvidovre
Denmark
Odense C
Denmark
Amiens Cedex 1 80
France
Bordeaux
France
Clichy
France
Lille
France
Marseille
France
Nice
France
Paris
France
Rouen
France
Aachen
Germany
Berlin
Germany
Berlin Be
Germany
Bochum
Germany
Frankfurt
Germany
Hamburg
Germany
Hanover
Germany
Heidelberg
Germany
Herne
Germany
Jena
Germany
Kiel
Germany
Magdeburg
Germany
Minden
Germany
München
Germany
Münster
Germany
Neustadt
Germany
Stade
Germany
Balatonfüred
Hungary
Budapest
Hungary
Debrecen
Hungary
Dunaújváros
Hungary
Gyõr
Hungary
Gyula
Hungary
Gyulai Ut 18
Hungary
Miskolc
Hungary
Mosonmagyaróvár
Hungary
Pécs
Hungary
Siófok
Hungary
Sopron
Hungary
Szeged
Hungary
Szekszárd
Hungary
Székesfehérvár
Hungary
Szombathely
Hungary
Veszprém
Hungary
Zalaegerszeg
Hungary
Bangalore
India
Chennai
India
Hyderabad
India
Hyderabad Andh Prad
India
Jaipur
India
Kārnād
India
Lucknow Gpo
India
Ludhiana
India
New Delhi
India
Pune
India
Vishakapatanam
India
Afula
Israel
Beer Yaakov
Israel
Beersheba
Israel
Haifa
Israel
Hedera
Israel
Jerusalem
Israel
Kfar Saba
Israel
Kiryat Bialik
Israel
Nazareth
Israel
Petah-Tikv
Israel
Rehovot
Israel
Tel Aviv
Israel
Tel Litwinsky
Israel
Bunkyō City
Japan
Chikushinoshi
Japan
Fukuoka
Japan
Hiroshima
Japan
Kagoshima
Japan
Kurashiki
Japan
Kurume
Japan
Nagoya
Japan
Nishinomiya
Japan
Okayama
Japan
Osaka
Japan
Sakura
Japan
Sapporo
Japan
Tokyo
Japan
Yokkaichi
Japan
Balvi
Latvia
Daugavpils
Latvia
Riga
Latvia
Kaunas
Lithuania
Klaipėda
Lithuania
Šiauliai
Lithuania
Vilnius
Lithuania
Vilnius Lt
Lithuania
Amsterdam
Netherlands
Ede Gld
Netherlands
Groningen
Netherlands
Leiden
Netherlands
Nieuwegein
Netherlands
Rotterdam
Netherlands
Auckland
New Zealand
Christchurch
New Zealand
Dunedin
New Zealand
Hamilton
New Zealand
Hastings
New Zealand
Bialystok
Poland
Bydgoszcz
Poland
Częstochowa
Poland
Elblag
Poland
Gdansk
Poland
Krakow
Poland
Lodz
Poland
Lublin
Poland
Opole
Poland
Skierniewice
Poland
Sopot
Poland
Szczecin
Poland
Torun
Poland
Warsaw
Poland
Bucharest
Romania
Cluj-Napoca
Romania
Iași
Romania
Târgu Mureş
Romania
Timișoara
Romania
Moscow
Russia
Novosibirsk
Russia
Omsk
Russia
Saint Petersburg
Russia
Smolensk
Russia
Yaroslavl
Russia
Belgrade
Serbia
Niš
Serbia
Zemun
Serbia
Bratislava
Slovakia
Martin
Slovakia
Nitra
Slovakia
Nové Mesto nad Váhom
Slovakia
Prešov
Slovakia
Trnava
Slovakia
Cape Town
South Africa
Cape Town West Cape
South Africa
Durban
South Africa
Plumstead West Cape
South Africa
Pretoria Gauteng
South Africa
Gothenburg
Sweden
Stockholm
Sweden
Donetsk
Ukraine
Ivano
Ukraine
Kharkiv
Ukraine
Kiev
Ukraine
Kyiv
Ukraine
Lviv
Ukraine
Poltava
Ukraine
Simferopol
Ukraine
Vinnitsa
Ukraine
Zhaporozhia 69104
Ukraine
Derived
Perrig K, Krupka N, Jordi SBU, Rossel JB, Biedermann L, Greuter T, Schreiner P, Vavricka SR, Juillerat P, Burri E, Zimmermann D, Maillard MH, Sulz MC, Brand S, Rogler G, Misselwitz B. Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Ther Adv Gastroenterol. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.
Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.
Philip G, Cornillie F, Adedokun JO, Melsheimer R, Rutgeerts P, Colombel JF, Marano C. Early Dose Optimisation of Golimumab in Nonresponders to Induction Treatment for Ulcerative Colitis Is Effective and Supported by Pharmacokinetic Data. J Crohns Colitis. 2019 Sep 27;13(10):1257-1264. doi: 10.1093/ecco-jcc/jjz052.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
FG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
FG004
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
FG005
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
FG006
Placebo Extension
Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
FG007
Golimumab 50 mg - Extension
Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
FG008
Golimumab 100 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
FG009
Golimumab 200 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
BG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
BG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
BG004
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
BG005
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000156
BG001154
BG002154
BG003129
BG004230
BG005405
BG0061228
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.2± 14.05
BG00141.4± 13.84
BG00239.1± 13.11
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00081
BG00177
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants in Clinical Response Through Week 54
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
OG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
OG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Units
Counts
Participants
OG000154
OG001151
OG002151
Title
Denominators
Categories
Title
Measurements
OG00048
OG00171
OG00275
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.010
A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
No
Superiority or Other
Secondary
Number of Participants With Clinical Remission at Both Week 30 and Week 54
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
OG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Secondary
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
OG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Secondary
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
OG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Secondary
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
12
156
88
156
EG001
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
13
154
102
154
EG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
22
154
94
154
EG003
GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
7
129
67
129
EG007
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
34
230
140
230
EG008
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
63
405
247
405
EG009
PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg
Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
7
56
30
56
EG010
Placebo Extension
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
8
96
43
96
EG011
Golimumab 50 mg Extension Phase
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
11
93
58
93
EG012
Golimumab 100 mg Extension
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
91
469
329
469
EG013
Golimumab 200 mg Extension
Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
1
7
6
7
EG014
Placebo - 50 mg Extension
A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
0
1
1
1
EG015
Placebo - Golimumab100 mg Extension
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
7
28
19
28
EG016
Golimumab 50 mg - 100 mg Extension
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
1
19
11
19
EG017
Golimumab 100 mg - 200 mg Extension
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
0
10
7
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG0030 affected76 at risk
EG0041 affected25 at risk
EG0050 affected14 at risk
EG0060 affected129 at risk
EG0071 affected230 at risk
EG0081 affected405 at risk
EG0090 affected56 at risk
EG0101 affected96 at risk
EG0111 affected93 at risk
EG0121 affected469 at risk
EG0130 affected7 at risk
EG0140 affected1 at risk
EG0150 affected28 at risk
EG0160 affected19 at risk
EG0170 affected10 at risk
Anaemia of Chronic Disease
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Aplastic Anaemia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Haemolytic Anaemia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Autoimmune Thyroiditis
Endocrine disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Blindness
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cataract
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Macular Fibrosis
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Anal Fissure
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0013 affected154 at risk
EG0026 affected154 at risk
EG003
Colon Dysplasia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Large Intestinal Stenosis
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Volvulus of Small Bowel
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Chest Pain
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Polyserositis
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Pyrexia
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Abscess Intestinal
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0023 affected154 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Brain Abscess
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Clostridium Difficile Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Cytomegalovirus Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Disseminated Tuberculosis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Encephalitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Escherichia Pyelonephritis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Extrapulmonary Tuberculosis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Gastroenteritis Rotavirus
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Infected Cyst
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Infectious Colitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Meningitis Viral
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Pelvic Sepsis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pilonidal Cyst
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pneumonia Legionella
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Postoperative Abscess
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pulmonary Tuberculosis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Septic Shock
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Staphylococcal Bacteraemia
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Streptococcal Sepsis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Tick-Borne Viral Encephalitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Accidental Poisoning
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Penetrating Abdominal Trauma
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Spondylopathy Traumatic
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Vascular Pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Liver Function Test Abnormal
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Seronegative Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Adrenal Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Colon Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Colon Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Gallbladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hodgkin's Disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Huerthle Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Ovarian Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Ovarian Epithelial Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Rectal Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Rectal Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Renal Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
T-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Convulsion
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Demyelination
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Facial Paresis
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Loss of Consciousness
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Multiple Sclerosis
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Nerve Root Compression
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Depression Suicidal
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Depressive Symptom
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Mental Disorder
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Substance Abuse
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Bladder Neck Obstruction
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pelvi-Ureteric Obstruction
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cervical Dysplasia
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Uterine Prolapse
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Vaginal Prolapse
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hypersensitivity Vasculitis
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Lichen Sclerosus
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pyoderma Gangrenosum
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Aortic Aneurysm Rupture
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Thrombophlebitis Superficial
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0014 affected154 at risk
EG0025 affected154 at risk
EG0032 affected76 at risk
EG0041 affected25 at risk
EG0050 affected14 at risk
EG0062 affected129 at risk
EG00710 affected230 at risk
EG00822 affected405 at risk
EG0091 affected56 at risk
EG0102 affected96 at risk
EG0111 affected93 at risk
EG01220 affected469 at risk
EG0131 affected7 at risk
EG0140 affected1 at risk
EG0151 affected28 at risk
EG0160 affected19 at risk
EG0170 affected10 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0012 affected154 at risk
EG0025 affected154 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Eye Irritation
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Myopia
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0022 affected154 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG00110 affected154 at risk
EG00211 affected154 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0014 affected154 at risk
EG0021 affected154 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG00029 affected156 at risk
EG00125 affected154 at risk
EG00218 affected154 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0012 affected154 at risk
EG0023 affected154 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0007 affected156 at risk
EG0014 affected154 at risk
EG0025 affected154 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0013 affected154 at risk
EG0022 affected154 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0011 affected154 at risk
EG0025 affected154 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0013 affected154 at risk
EG0023 affected154 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0017 affected154 at risk
EG0027 affected154 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0005 affected156 at risk
EG0012 affected154 at risk
EG0023 affected154 at risk
EG003
Chest Pain
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0022 affected154 at risk
EG003
Fatigue
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0014 affected154 at risk
EG0026 affected154 at risk
EG003
Feeling Cold
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0012 affected154 at risk
EG0021 affected154 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0024 affected154 at risk
EG003
Injection Site Induration
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Injection Site Oedema
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Injection Site Rash
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0022 affected154 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0024 affected154 at risk
EG003
Pain
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pyrexia
General disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0007 affected156 at risk
EG0016 affected154 at risk
EG0023 affected154 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0012 affected154 at risk
EG0021 affected154 at risk
EG003
Acute Tonsillitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0012 affected154 at risk
EG0020 affected154 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0016 affected154 at risk
EG0021 affected154 at risk
EG003
Chlamydial Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Clostridium Difficile Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Eyelid Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0012 affected154 at risk
EG0023 affected154 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0012 affected154 at risk
EG0020 affected154 at risk
EG003
Giardiasis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0012 affected154 at risk
EG0020 affected154 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0017 affected154 at risk
EG0022 affected154 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG00010 affected156 at risk
EG00114 affected154 at risk
EG00223 affected154 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0012 affected154 at risk
EG0022 affected154 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0017 affected154 at risk
EG0025 affected154 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0016 affected154 at risk
EG0026 affected154 at risk
EG003
Skin Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Tinea Cruris
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0018 affected154 at risk
EG0028 affected154 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0013 affected154 at risk
EG0021 affected154 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0012 affected154 at risk
EG0021 affected154 at risk
EG003
Viral Pharyngitis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0021 affected154 at risk
EG003
Animal Bite
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Bite
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0022 affected154 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Toxicity to Various Agents
Injury, poisoning and procedural complications
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0023 affected154 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0015 affected154 at risk
EG0022 affected154 at risk
EG003
Blood Calcium Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Blood Parathyroid Hormone Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Neutrophil Count Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Vitamin D Decreased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0012 affected154 at risk
EG0020 affected154 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0022 affected154 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG00011 affected156 at risk
EG00111 affected154 at risk
EG0029 affected154 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0013 affected154 at risk
EG0027 affected154 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0013 affected154 at risk
EG0021 affected154 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Demyelination
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG00014 affected156 at risk
EG00113 affected154 at risk
EG00212 affected154 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0020 affected154 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0012 affected154 at risk
EG0022 affected154 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0023 affected154 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0011 affected154 at risk
EG0022 affected154 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected154 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Cervix Haemorrhage Uterine
Reproductive system and breast disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0005 affected156 at risk
EG0015 affected154 at risk
EG0028 affected154 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0013 affected154 at risk
EG0026 affected154 at risk
EG003
Upper Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0002 affected156 at risk
EG0012 affected154 at risk
EG0021 affected154 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0010 affected154 at risk
EG0024 affected154 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Dermal Cyst
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0003 affected156 at risk
EG0019 affected154 at risk
EG0026 affected154 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Hot Flush
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0001 affected156 at risk
EG0011 affected154 at risk
EG0020 affected154 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0004 affected156 at risk
EG0011 affected154 at risk
EG0021 affected154 at risk
EG003
Phlebitis
Vascular disorders
MedDRA Version 17.1
Non-systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected154 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
12 months after study ends, sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication & it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which investigator will be free to publish. The participation of sponsor will be acknowledged.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director
Janssen Research & Development
215-793-7540
ID
Term
D003093
Colitis, Ulcerative
Ancestor Terms
ID
Term
D003092
Colitis
D005759
Gastroenteritis
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
D015212
Inflammatory Bowel Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C529000
golimumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
56 subjects
FG005124 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
3 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
14 subjects
FG00534 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG00616 subjects
FG00766 subjects
FG008288 subjects
FG0094 subjects
0 subjects
FG0050 subjects
FG00680 subjects
FG00727 subjects
FG008182 subjects
FG0093 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG00610 subjects
FG0078 subjects
FG00854 subjects
FG0090 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Unsatisfactory therapeutic effect
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0075 subjects
FG00834 subjects
FG0093 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0086 subjects
FG0090 subjects
Unspecified reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00663 subjects
FG00714 subjects
FG00887 subjects
FG0090 subjects
38
± 13.27
BG00440.3± 12.67
BG00541.2± 13.6
BG00640.3± 13.44
65
BG00368
BG00499
BG005138
BG006528
Male
BG00075
BG00177
BG00289
BG00361
BG004131
BG005267
BG006700
OG000
OG002
Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
<0.001
A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
No
Superiority or Other
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
OG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Units
Counts
Participants
OG000154
OG001151
OG002151
Title
Denominators
Categories
Title
Measurements
OG00024
OG00135
OG00242
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.122
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
OG000
OG002
Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.004
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
OG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Units
Counts
Participants
OG000154
OG001151
OG002151
Title
Denominators
Categories
Title
Measurements
OG00041
OG00163
OG00264
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.011
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
OG000
OG002
Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.002
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
OG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Units
Counts
Participants
OG00054
OG00152
OG00254
Title
Denominators
Categories
Title
Measurements
OG00013
OG00119
OG00221
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
Cochran-Mantel-Haenszel
0.365
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
OG000
OG002
Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
Cochran-Mantel-Haenszel
0.098
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
OG002
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Units
Counts
Participants
OG00087
OG00178
OG00282
Title
Denominators
Categories
Title
Measurements
OG00016
OG00122
OG00219
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.279
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
No
Superiority or Other
OG000
OG002
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
Cochran-Mantel-Haenszel
0.423
Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.