Study Of Celecoxib Or Diclofenac And Omeprazole For Gastr... | NCT00141102

Label	Type	Description	Intervention Names
A	Experimental		Drug: Celecoxib
B	Active Comparator		Drug: Diclofenac + Omeprazole

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	Participants are assigned to one of two groups in parallel for the duration of the study	A

Measure	Description	Time Frame
Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)	CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.	6 month treatment duration

Measure	Description	Time Frame
Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)	CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.

Measure	Description	Time Frame
Number of Subjects Alive at the Post Trial Interview	Interview occurred via telephone to obtain follow-up mortality and hospitalization information.	6 months following last dose
Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Genk		3600	Belgium
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
24358067	Derived	Kellner HL, Li C, Essex MN. Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial. Open Rheumatol J. 2013 Nov 13;7:96-100. doi: 10.2174/1874312901307010096. eCollection 2013.
20638563	Derived	Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. doi: 10.1016/S0140-6736(10)60673-3. Epub 2010 Jun 16.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Celecoxib	200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
FG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

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 Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.

Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG0002238 OG0012246

Title

Denominators

Categories

Title	Measurements
	OG00020 OG00181

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		Life Table Extension	Stratified by history of GD ulceration and by region.	<0.0001		Odds Ratio (OR)	4.32			2-Sided								Superiority or Other (legacy)

Secondary

Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)

CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.

ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants

Secondary

Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)

Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.

ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.

Posted

Least Squares Mean

Standard Error

scores on a scale

Month 6/Early Termination (ET)

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With SUs

Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.

ITT.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With CSULGIEs by History of GD Ulceration

ITT. n = number of subjects who had history or no history of GD ulceration.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants

Secondary

Number of Subjects With Moderate to Severe Abdominal Symptoms

Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".

ITT

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Withdrawn Due to GI Adverse Events (AEs)

GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.

ITT

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hemoglobin at Month 6/ET

Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

grams (g)/deciliter (dL)

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematocrit at Month 6/ET

Safety population. Number of Participants Analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

percent

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin

A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.

Safety population. Number of Participants Analyzed = number of subjects with analyzable data.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)

GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.

Safety population. Number of participants analyzed = number of subjects with analyzable data.

Posted

Number

participants

6 month treatment duration

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET

Safety population. Number of participants analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

IU/L

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Iron Binding Capacity to Month 6/ET

Safety population. Number of participants analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

microgram (ug)/dL

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Ferretin to Month 6/ET

Safety population. Number of participants analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

ug/dL

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in C-Reactive Protein to Month 6/ET

Safety population. Number of participants analyzed = number of subjects with analyzable data.

Posted

Least Squares Mean

Standard Error

mg/dL

Month 6/ET

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Subjects Alive at the Post Trial Interview

Interview occurred via telephone to obtain follow-up mortality and hospitalization information.

Safety population. Number of participants analyzed = number of subjects with follow-up information available.

Posted

Number

participants

6 months following last dose

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview

Interview occurred via telephone to obtain follow-up mortality and hospitalization information.

Safety population. Number of participants analyzed = number of subjects with follow-up information available.

Posted

Number

participants

6 months following last dose

ID	Title	Description
OG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
OG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0012 affected2,237 at risk
Angina unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Colitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0010 affected2,237 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Enteritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0012 affected2,237 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0013 affected2,237 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Disease progression	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected2,223 at risk EG0011 affected2,237 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0012 affected2,237 at risk
Acute sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Appendicitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Arthritis bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Bronchopneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Burn infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0011 affected2,237 at risk
Chronic sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Device related infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Erysipelas	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Groin abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Osteomyelitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Pyothorax	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0012 affected2,237 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Eye burns	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0012 affected2,237 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected2,223 at risk EG0014 affected2,237 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Balance disorder	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0012 affected2,237 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Dysarthria	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Facial palsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0011 affected2,237 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0012 affected2,237 at risk
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0010 affected2,237 at risk
Major depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Suicide attempt	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected2,223 at risk EG0010 affected2,237 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Open reduction of fracture	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Prolapse repair	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Rectocele repair	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Embolism	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected2,223 at risk EG0011 affected2,237 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected2,223 at risk EG0010 affected2,237 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D011725	Pyridines
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo
BG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Celecoxib	200 mg BID plus omeprazole placebo and diclofenac SR placebo			61	2,223	530	2,223
EG001	Oral Diclofenac Plus Omeprazole	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.			61	2,237	669	2,237