GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared Wi... | NCT00373685

Label	Type	Description	Intervention Names
Celecoxib	Experimental	dosing as per USPI label	Drug: Celecoxib
NSAIDs	Active Comparator		Drug: Any commercially available NSAID with the indication for osteoarthritis

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	open-label	Celecoxib
Any commercially available NSAID with the indication for osteoarthritis

Measure	Description	Time Frame
Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)	CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.	Baseline through week 24 or Early Termination (ET)

Measure	Description	Time Frame
Percentage of Participants With Moderate to Severe Abdominal Symptoms	Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.

Measure	Description	Time Frame
Percentage of Participants With Positive Blood Fecal Occult	Positive blood fecal occult; blood in feces that is not visibly apparent	Week 24 or ET
Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Abbeville	Alabama	36310	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
23399552	Derived	Cryer B, Li C, Simon LS, Singh G, Stillman MJ, Berger MF. GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Am J Gastroenterol. 2013 Mar;108(3):392-400. doi: 10.1038/ajg.2012.467. Epub 2013 Feb 12.

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

ID	Title	Description
FG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
FG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

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

Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.

Intent-to-Treat (ITT) Population: randomized participants

Posted

Number

Percentage of participants

Baseline through week 24 or Early Termination (ET)

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG0004035 OG0014032

Title

Denominators

Categories

Title	Measurements
	OG0001.3 OG0012.4

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 of CMH Test		0.0003	Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test					2-Sided								Superiority or Other (legacy)

Secondary

Percentage of Participants With Moderate to Severe Abdominal Symptoms

Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.

ITT;

Posted

Number

Percentage of participants

Baseline through week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)

GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions

ITT

Posted

Number

Percentage of participants

Baseline through week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Hemoglobin (Hb) at Baseline

ITT; N= number of evaluable participants analyzed

Posted

Mean

Standard Deviation

gram per deciliter (g/dL)

Baseline

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Change From Baseline Hb at Week 24

ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)

Posted

Least Squares Mean

Standard Error

g/dL

Baseline and Week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Hematocrit (Hct) at Baseline

ITT; N= number of evaluable participants analyzed

Posted

Mean

Standard Deviation

Percent

Baseline

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Change From Baseline Hct at Week 24

ITT; N= number of evaluable participants analyzed; LOCF

Posted

Least Squares Mean

Standard Error

Percent

Baseline and Week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline

Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).

ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF

Posted

Number

Percentage of participants

Baseline, Weeks 8, 16, 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall

Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).

ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF

Posted

Number

Percentage of participants

Baseline, Weeks 8, 16, 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief

Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF

Posted

Number

Percentage of participants

Baseline, Weeks 8, 16, 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief

Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF

Posted

Number

Percentage of participants

Baseline, Weeks 8, 16, 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief

Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF

Posted

Number

Percentage of participants

Baseline, Weeks 8, 16, 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With Positive Blood Fecal Occult

Positive blood fecal occult; blood in feces that is not visibly apparent

ITT

Posted

Number

Percentage of participants

Week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization

PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.

ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed

Posted

Number

Percentage of participants

Baseline through week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With Non-study Medication Utilization

Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.

ITT; N= number of evaluable participants analyzed

Posted

Number

Percentage of participants

Baseline through week 24 or ET

ID	Title	Description
OG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
OG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0003 affected3,970 at risk EG0011 affected3,951 at risk
Bradycardia	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Coronary artery disease	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0011 affected3,951 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Myocardial infarction	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0003 affected3,970 at risk EG0011 affected3,951 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Palpitations	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Tachycardia	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0011 affected3,951 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0012 affected3,951 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Bezoar	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0011 affected3,951 at risk
Gastritis	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Ileus	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Nausea	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Peritonitis	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Asthenia	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Chest pain	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG00010 affected3,970 at risk EG0017 affected3,951 at risk
Device dislocation	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Malaise	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Non-cardiac chest pain	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Pain	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Performance status decreased	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0003 affected3,970 at risk EG0010 affected3,951 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Appendicitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0013 affected3,951 at risk
Bronchitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0012 affected3,951 at risk
Bronchopneumonia	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Cellulitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0012 affected3,951 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Diverticulitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0003 affected3,970 at risk EG0013 affected3,951 at risk
Empyema	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Endocarditis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Gastroenteritis viral	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Localised infection	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Pneumonia	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0005 affected3,970 at risk EG0013 affected3,951 at risk
Scrotal abscess	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Urinary tract infection	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0011 affected3,951 at risk
Vaginal abscess	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Bone fragmentation	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Injury	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Peroneal nerve injury	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Renal haematoma	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Blood amylase increased	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Blood glucose increased	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Heart rate increased	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Lipase increased	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Liver function test abnormal	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Occult blood positive	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0013 affected3,951 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0009 affected3,970 at risk EG0013 affected3,951 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0011 affected3,951 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0004 affected3,970 at risk EG0012 affected3,951 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Colon cancer	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0004 affected3,970 at risk EG0011 affected3,951 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0012 affected3,951 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Dizziness	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Loss of consciousness	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Paraesthesia	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0013 affected3,951 at risk
Sciatica	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Syncope	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Thrombotic stroke	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Completed suicide	Psychiatric disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Depression	Psychiatric disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Panic attack	Psychiatric disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Suicidal ideation	Psychiatric disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0012 affected3,951 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Incontinence	Renal and urinary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Nephrocalcinosis	Renal and urinary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0010 affected3,951 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0005 affected3,970 at risk EG0012 affected3,951 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Breast lump removal	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Colectomy	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Foot amputation	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0012 affected3,951 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Aortic aneurysm	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Aortic stenosis	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0010 affected3,951 at risk
Arteriosclerosis obliterans	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0001 affected3,970 at risk EG0011 affected3,951 at risk
Hypertension	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0002 affected3,970 at risk EG0010 affected3,951 at risk
Hypotension	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Intermittent claudication	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk
Thrombophlebitis	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG0000 affected3,970 at risk EG0011 affected3,951 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic 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

ID	Title	Description
BG000	Celecoxib	Celecoxib open-label per United States Package Insert (US PI) recommended dosing
BG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
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	Celecoxib open-label per United States Package Insert (US PI) recommended dosing			99	3,970	962	3,970
EG001	nsNSAIDs	Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing			95	3,951	1,163	3,951

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00030 affected3,970 at risk EG00152 affected3,951 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00037 affected3,970 at risk EG00159 affected3,951 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00037 affected3,970 at risk EG00160 affected3,951 at risk
Constipation	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00036 affected3,970 at risk EG00170 affected3,951 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00084 affected3,970 at risk EG001115 affected3,951 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00065 affected3,970 at risk EG00198 affected3,951 at risk
Gastritis	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00032 affected3,970 at risk EG00139 affected3,951 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00029 affected3,970 at risk EG00178 affected3,951 at risk
Nausea	Gastrointestinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00065 affected3,970 at risk EG001112 affected3,951 at risk
Oedema peripheral	General disorders	MedDRA version 13.1	Non-systematic Assessment	EG00050 affected3,970 at risk EG00167 affected3,951 at risk
Bronchitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG00086 affected3,970 at risk EG00177 affected3,951 at risk
Sinusitis	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG00075 affected3,970 at risk EG00188 affected3,951 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG000112 affected3,970 at risk EG00175 affected3,951 at risk
Urinary tract infection	Infections and infestations	MedDRA version 13.1	Non-systematic Assessment	EG00070 affected3,970 at risk EG00175 affected3,951 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 13.1	Non-systematic Assessment	EG00044 affected3,970 at risk EG00164 affected3,951 at risk
Haemoglobin decreased	Investigations	MedDRA version 13.1	Non-systematic Assessment	EG00059 affected3,970 at risk EG00184 affected3,951 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG00082 affected3,970 at risk EG00173 affected3,951 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG00042 affected3,970 at risk EG00143 affected3,951 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG00029 affected3,970 at risk EG00139 affected3,951 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG00059 affected3,970 at risk EG00147 affected3,951 at risk
Dizziness	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG00043 affected3,970 at risk EG00151 affected3,951 at risk
Headache	Nervous system disorders	MedDRA version 13.1	Non-systematic Assessment	EG00067 affected3,970 at risk EG00183 affected3,951 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Non-systematic Assessment	EG00042 affected3,970 at risk EG00141 affected3,951 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 13.1	Non-systematic Assessment	EG00040 affected3,970 at risk EG00144 affected3,951 at risk
Hypertension	Vascular disorders	MedDRA version 13.1	Non-systematic Assessment	EG00035 affected3,970 at risk EG00145 affected3,951 at risk