CONDOR: Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00141102
• Collaborator: (none)
• Enrollment: 4,484
• Locations: 195
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 23
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Arthritis, Rheumatoid	Drug: Celecoxib; Drug: Diclofenac + Omeprazole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 4484 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Celecoxib; Participants are assigned to one of two groups in parallel for the duration of the study
Active Comparator: B	Drug: Diclofenac + Omeprazole; Participants are assigned to one of two groups in parallel for the duration of the study

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) [6 month treatment duration]

   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.

Secondary Outcome Measures

1. Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) [6 month treatment duration]

   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.

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

3. Number of Subjects With SUs [6 month treatment duration]

   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.

4. Number of Subjects With CSULGIEs by History of GD Ulceration [6 month treatment duration]

   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.

5. Number of Subjects With Moderate to Severe Abdominal Symptoms [6 month treatment duration]

   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".

6. Number of Subjects Withdrawn Due to GI Adverse Events (AEs) [6 month treatment duration]

   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.

7. Change From Baseline in Hemoglobin at Month 6/ET [Month 6/ET]

8. Change From Baseline in Hematocrit at Month 6/ET [Month 6/ET]

9. Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin [6 month treatment duration]

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

10. 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) [6 month treatment duration]

    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.

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

12. Change From Baseline in Iron Binding Capacity to Month 6/ET [Month 6/ET]

13. Change From Baseline in Ferretin to Month 6/ET [Month 6/ET]

14. Change From Baseline in C-Reactive Protein to Month 6/ET [Month 6/ET]

Other Outcome Measures

1. Number of Subjects Alive at the Post Trial Interview [6 months following last dose]

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

2. Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview [6 months following last dose]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management

• Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

• Active GD ulceration or GD ulceration within 90 days of the screening visit.

• Concomitant use of low dose aspirin

• Previous MI, stroke or significant vascular disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Genk		Belgium	3600
2	Pfizer Investigational Site	Gent		Belgium	9000
3	Pfizer Investigational Site	Hasselt		Belgium	3500
4	Pfizer Investigational Site	Liège		Belgium	4000
5	Pfizer Investigational Site	Goiânia	GO	Brazil	74043-110
6	Pfizer Investigational Site	Goiânia	GO	Brazil	74110-120
7	Pfizer Investigational Site	Curitiba	PR	Brazil	80060-240
8	Pfizer Investigational Site	Curitiba	PR	Brazil	80060-900
9	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	22271-100
10	Pfizer Investigational Site	Porto Alegre	RS	Brazil	90035-903
11	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04230-000
12	Pfizer Investigational Site	São Paulo	SP	Brazil	05403-010
13	Pfizer Investigational Site	São Paulo	SP	Brazil	05437-010
14	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3A 1M3
15	Pfizer Investigational Site	St. John's	Newfoundland and Labrador	Canada	A1B 3E1
16	Pfizer Investigational Site	Hamilton	Ontario	Canada	L8N 1Y2
17	Pfizer Investigational Site	Newmarket	Ontario	Canada	L3Y 3R7
18	Pfizer Investigational Site	Windsor	Ontario	Canada	N8X 5A6
19	Pfizer Investigational Site	Pointe Claire	Quebec	Canada	H9R 3J1
20	Pfizer Investigational Site	Sherbrooke	Quebec	Canada	J1H 5N4
21	Pfizer Investigational Site	Ste Foy	Quebec	Canada	G1V 3M7
22	Pfizer Investigational Site	Guangzhou	Guangdong	China	510630
23	Pfizer Investigational Site	Nanjing	Jiangsu	China	210008
24	Pfizer Investigational Site	Chengdu	Sichuan	China	610041
25	Pfizer Investigational Site	Beijing		China	100020
26	Pfizer Investigational Site	Beijing		China	100044
27	Pfizer Investigational Site	Beijing		China	100073
28	Pfizer Investigational Site	Beijing		China	100853
29	Pfizer Investigational Site	Shanghai		China	200001
30	Pfizer Investigational Site	Shanghai		China	200040
31	Pfizer Investigational Site	Tianjin		China	300052
32	Pfizer Investigational Site	Tianjin		China	300192
33	Pfizer Investigational Site	Medellin	Antioquia	Colombia	0
34	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia	0
35	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia
36	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	0
37	Pfizer Investigational Site	Floridablanca	Santander	Colombia	0
38	Pfizer Investigational Site	Cartago		Costa Rica
39	Pfizer Investigational Site	Heredia		Costa Rica
40	Pfizer Investigational Site	San Jose		Costa Rica	3er piso.
41	Pfizer Investigational Site	San Jose		Costa Rica
42	Pfizer Investigational Site	Opatija		Croatia	51410
43	Pfizer Investigational Site	Zagreb		Croatia	10000
44	Pfizer Investigational Site	Plzen	Bory	Czechia	30599
45	Pfizer Investigational Site	Ostrava	Trebovice	Czechia	722 00
46	Pfizer Investigational Site	Ceske Budejovice		Czechia	370 01
47	Pfizer Investigational Site	Hradec Kralove		Czechia	50012
48	Pfizer Investigational Site	Prague 1		Czechia	118 00
49	Pfizer Investigational Site	Praha 2		Czechia	120 00
50	Pfizer Investigational Site	Praha 2		Czechia	128 50
51	Pfizer Investigational Site	Praha 4		Czechia	140 59
52	Pfizer Investigational Site	Praha 6		Czechia	16900
53	Pfizer Investigational Site	Cuenca	Azuay	Ecuador
54	Pfizer Investigational Site	Guayaquil	Guayas	Ecuador
55	Pfizer Investigational Site	Quito	Pichincha	Ecuador
56	Pfizer Investigational Site	Tallinn		Estonia	11312
57	Pfizer Investigational Site	Tallinn		Estonia	13419
58	Pfizer Investigational Site	Tartu		Estonia	51007
59	Pfizer Investigational Site	Amiens		France	80030
60	Pfizer Investigational Site	Dijon		France	21000
61	Pfizer Investigational Site	Berlin		Germany	12247
62	Pfizer Investigational Site	Berlin		Germany	13125
63	Pfizer Investigational Site	Deggingen		Germany	73326
64	Pfizer Investigational Site	Dresden		Germany	01129
65	Pfizer Investigational Site	Hamburg		Germany	22143
66	Pfizer Investigational Site	Hamburg		Germany	22415
67	Pfizer Investigational Site	Hoyerswerda		Germany	02977
68	Pfizer Investigational Site	Kuenzing		Germany	94550
69	Pfizer Investigational Site	Muenchen		Germany	80639
70	Pfizer Investigational Site	Nuernberg		Germany	90402
71	Pfizer Investigational Site	Thessaloniki		Greece	54 636
72	Pfizer Investigational Site	Ciudad de Guatemala		Guatemala
73	Pfizer Investigational Site	Guatemala 01010		Guatemala
74	Pfizer Investigational Site	Lai Chi Kok		Hong Kong
75	Pfizer Investigational Site	Shatin		Hong Kong
76	Pfizer Investigational Site	Hyderabad	Andhra Pradesh	India	500 033
77	Pfizer Investigational Site	Bangalore	Karnataka	India	560 034
78	Pfizer Investigational Site	Bangalore	Karnataka	India	560 079
79	Pfizer Investigational Site	Bangalore	Karnataka	India	560054
80	Pfizer Investigational Site	Ludhiana	Punjab	India	141 001
81	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
82	Pfizer Investigational Site	Seoul		Korea, Republic of	133-792
83	Pfizer Investigational Site	Seoul		Korea, Republic of	135-710
84	Pfizer Investigational Site	Seoul		Korea, Republic of	137-040
85	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
86	Pfizer Investigational Site	Riga		Latvia	LV 1002
87	Pfizer Investigational Site	Riga		Latvia	LV 1006
88	Pfizer Investigational Site	Riga		Latvia	LV 1038
89	Pfizer Investigational Site	Alytus		Lithuania	LT-62114
90	Pfizer Investigational Site	Kaunas		Lithuania	LT-47144
91	Pfizer Investigational Site	Kaunas		Lithuania	LT-50425
92	Pfizer Investigational Site	Klaipeda		Lithuania	LT-94231
93	Pfizer Investigational Site	Vilnius		Lithuania	LT-07156
94	Pfizer Investigational Site	Vlaardingen	ZH	Netherlands	3136 LA
95	Pfizer Investigational Site	Alkmaar		Netherlands	1815 JD
96	Pfizer Investigational Site	Leidschendam		Netherlands	2262 BA
97	Pfizer Investigational Site	Ciudad de Panama		Panama
98	Pfizer Investigational Site	Surco	Lima	Peru	Lima 33
99	Pfizer Investigational Site	Lima		Peru	27
100	Pfizer Investigational Site	Lima		Peru	L11
101	Pfizer Investigational Site	Lima		Peru	Lima 27
102	Pfizer Investigational Site	Lima		Peru	Lima 29
103	Pfizer Investigational Site	Lisboa		Portugal	1249-075
104	Pfizer Investigational Site	Lisboa		Portugal	1600-035
105	Pfizer Investigational Site	Lisbon		Portugal	1000-247
106	Pfizer Investigational Site	Ponta Delgada		Portugal	9500-370
107	Pfizer Investigational Site	Ponte de Lima		Portugal	4990-049
108	Pfizer Investigational Site	Ponte de Lima		Portugal	4990-49
109	Pfizer Investigational Site	Ekaterinburg		Russian Federation	620043
110	Pfizer Investigational Site	Moscow		Russian Federation	109004
111	Pfizer Investigational Site	Moscow		Russian Federation	109240
112	Pfizer Investigational Site	Moscow		Russian Federation	109388
113	Pfizer Investigational Site	Moscow		Russian Federation	113093
114	Pfizer Investigational Site	Moscow		Russian Federation	115522
115	Pfizer Investigational Site	Moscow		Russian Federation	118089
116	Pfizer Investigational Site	Petrozavodsk		Russian Federation	185019
117	Pfizer Investigational Site	Smolensk		Russian Federation	214019
118	Pfizer Investigational Site	St. Petersburg		Russian Federation	190000
119	Pfizer Investigational Site	St. Petersburg		Russian Federation
120	Pfizer Investigational Site	Belgrade		Serbia	11000
121	Pfizer Investigational Site	Niska Banja		Serbia	18205
122	Pfizer Investigational Site	Novi Sad		Serbia	21000
123	Pfizer Investigational Site	Sinapore		Singapore	308433
124	Pfizer Investigational Site	Singapore		Singapore	119074
125	Pfizer Investigational Site	Singapore		Singapore	529889
126	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9310
127	Pfizer Investigational Site	Johannesburg	Gauteng Province	South Africa	2193
128	Pfizer Investigational Site	Durban	KZN	South Africa	4091
129	Pfizer Investigational Site	Parow	Western Cape	South Africa	7500
130	Pfizer Investigational Site	Bellville		South Africa	7530
131	Pfizer Investigational Site	Cape Town		South Africa
132	Pfizer Investigational Site	Kempton Park		South Africa
133	Pfizer Investigational Site	Observatory Cape Town		South Africa	7925
134	Pfizer Investigational Site	Partida DE Bacarot	Alicante	Spain	03114
135	Pfizer Investigational Site	Oviedo	Asturias	Spain	33006
136	Pfizer Investigational Site	Sabadell	Barcelona	Spain	08208
137	Pfizer Investigational Site	Barakaldo	Vizcaya	Spain	48903
138	Pfizer Investigational Site	Avila		Spain	05004
139	Pfizer Investigational Site	Barcelona		Spain	08036
140	Pfizer Investigational Site	Barcelona		Spain	08041
141	Pfizer Investigational Site	Madrid		Spain	28009
142	Pfizer Investigational Site	Madrid		Spain	28046
143	Pfizer Investigational Site	Zaragoza		Spain	50009
144	Pfizer Investigational Site	Goteborg		Sweden	400 10
145	Pfizer Investigational Site	Goteborg		Sweden	400 14
146	Pfizer Investigational Site	Lulea		Sweden	972 33
147	Pfizer Investigational Site	Norrkoping		Sweden	602 32
148	Pfizer Investigational Site	Kaohsiung Hsien		Taiwan
149	Pfizer Investigational Site	Taichung		Taiwan	407
150	Pfizer Investigational Site	Tainan		Taiwan	407
151	Pfizer Investigational Site	Taipei		Taiwan	114
152	Pfizer Investigational Site	Tao-Yuan		Taiwan
153	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49008
154	Pfizer Investigational Site	Donetsk		Ukraine	83003
155	Pfizer Investigational Site	Donetsk		Ukraine	83114
156	Pfizer Investigational Site	Ivano-Frankivsk		Ukraine	76018
157	Pfizer Investigational Site	Kharkiv		Ukraine	61002
158	Pfizer Investigational Site	Kharkiv		Ukraine	61018
159	Pfizer Investigational Site	Kharkiv		Ukraine	61037
160	Pfizer Investigational Site	Kharkiv		Ukraine	61178
161	Pfizer Investigational Site	Kiev		Ukraine	01103
162	Pfizer Investigational Site	Kyiv		Ukraine	04053
163	Pfizer Investigational Site	Lutsk		Ukraine	43024
164	Pfizer Investigational Site	Lviv		Ukraine	79013
165	Pfizer Investigational Site	Odessa		Ukraine	65009
166	Pfizer Investigational Site	Odessa		Ukraine	65025
167	Pfizer Investigational Site	Odessa		Ukraine	65026
168	Pfizer Investigational Site	Simferopol		Ukraine	95017
169	Pfizer Investigational Site	Zaporizhzhia		Ukraine	69118
170	Pfizer Investigational Site	Helensburgh	Argyle & Clyde	United Kingdom	G84 7QL
171	Pfizer Investigational Site	Maidenhead	Berks	United Kingdom	SL6 6EL
172	Pfizer Investigational Site	Aston Clinton	Buckinghamshire	United Kingdom	HP22 5LB
173	Pfizer Investigational Site	St Austell	Cornwall	United Kingdom	PL26 7RL
174	Pfizer Investigational Site	Bexhill on Sea	East Sussex	United Kingdom	TN39 4SP
175	Pfizer Investigational Site	Aldershot	Hampshire	United Kingdom	GU12 5BA
176	Pfizer Investigational Site	Basingstoke	Hampshire	United Kingdom	RG22 4EH
177	Pfizer Investigational Site	Odiham	Hampshire	United Kingdom	RG29 1JY
178	Pfizer Investigational Site	Ashford	Middlesex	United Kingdom	TW15 3EA
179	Pfizer Investigational Site	Harrow	Middlesex	United Kingdom	HA3 7LT
180	Pfizer Investigational Site	Camberley	Surrey	United Kingdom	GU15 2NN
181	Pfizer Investigational Site	East Horsley, Leatherhead	Surrey	United Kingdom	KT24 6QT
182	Pfizer Investigational Site	Pound Hill, Crawley	WEST Sussex	United Kingdom	RH10 7DX
183	Pfizer Investigational Site	Bradford-on-Avon	Wiltshire	United Kingdom	BA1 5DQ
184	Pfizer Investigational Site	Chippenham	Wiltshire	United Kingdom	SN14 6GT
185	Pfizer Investigational Site	Upton	Wirral	United Kingdom	L49 5PE
186	Pfizer Investigational Site	Bexhill on Sea		United Kingdom	TN39 5HE
187	Pfizer Investigational Site	Canterbury		United Kingdom	CT1 3HX
188	Pfizer Investigational Site	Chesterfield		United Kingdom	S40 4TF
189	Pfizer Investigational Site	Glasgow		United Kingdom	G42 7AF
190	Pfizer Investigational Site	Peterborough		United Kingdom	PE2 5GP
191	Pfizer Investigational Site	Peterborough		United Kingdom	PE7 3JL
192	Pfizer Investigational Site	St Leonards on Sea		United Kingdom	TN37 6BG
193	Pfizer Investigational Site	Swindon		United Kingdom	SN25 4YZ
194	Pfizer Investigational Site	Vale Of Glamorgan		United Kingdom	CF62 7EB
195	Pfizer Investigational Site	Wansford		United Kingdom	PE8 6PL

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00141102
• Other Study ID Numbers: A3191084
• First Posted: Sep 1, 2005
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: GI events in high risk GI arthritis patients
• Additional relevant MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Celecoxib; Diclofenac; Omeprazole

Study Results

Participant Flow

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Period Title: Overall Study
STARTED	2238	2246
Received Treatment	2223	2237
COMPLETED	1730	1621
NOT COMPLETED	508	625

Baseline Characteristics

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole	Total
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.	Total of all reporting groups
Overall Participants	2238	2246	4484
Age, Customized (participants) [Number]
< 55 years	176 7.9%	164 7.3%	340 7.6%
55 to 59 years	122 5.5%	113 5%	235 5.2%
60 to 64 years	721 32.2%	742 33%	1463 32.6%
65 to 69 years	623 27.8%	618 27.5%	1241 27.7%
70 to 74 years	361 16.1%	390 17.4%	751 16.7%
> = 75 years	235 10.5%	219 9.8%	454 10.1%
Sex: Female, Male (Count of Participants)
Female	1848 82.6%	1822 81.1%	3670 81.8%
Male	390 17.4%	424 18.9%	814 18.2%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2238	2246
Number [participants]	20 0.9%	81 3.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Life Table Extension
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.32
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2238	2246
Number [participants]	25 1.1%	92 4.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Life Table Extension
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.93
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)
Description	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.
Time Frame	Month 6/Early Termination (ET)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2207	2213
Least Squares Mean (Standard Error) [scores on a scale]	0.754 (0.020)	0.773 (0.019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4146
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-0.019
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.023
	Estimation Comments

4. Secondary Outcome

Title	Number of Subjects With SUs
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

ITT.

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2238	2246
Number [participants]	5 0.2%	11 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1132
	Comments
	Method	Life Table Extension
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.29
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Subjects With CSULGIEs by History of GD Ulceration
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2238	2246
History of GD Ulceration (n=395, 400)	7 0.3%	13 0.6%
No History of GD Ulceration (n=1843, 1846)	13 0.6%	68 3%

6. Secondary Outcome

Title	Number of Subjects With Moderate to Severe Abdominal Symptoms
Description	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".
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2238	2246
Number [participants]	132 5.9%	162 7.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0495
	Comments
	Method	Life Table Extension
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.26
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Measure Participants	2238	2246
Number [participants]	114 5.1%	167 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Life Table Extension
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Hemoglobin at Month 6/ET
Time Frame	Month 6/ET

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2184	2167
Least Squares Mean (Standard Error) [grams (g)/deciliter (dL)]	-0.017 (0.019)	-0.423 (0.019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.406
	Confidence Interval	(2-Sided) 95%; 0.36 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.022
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Hematocrit at Month 6/ET
Time Frame	Month 6/ET

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2184	2167
Least Squares Mean (Standard Error) [percent]	-0.306 (0.059)	-1.425 (0.059)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.118
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.069
	Estimation Comments

10. Secondary Outcome

Title	Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin
Description	A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2184	2167
Number [participants]	45 2%	123 5.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by history of GD ulceration and by region.
Method of Estimation	Estimation Parameter	Relative Risk
	Estimated Value	2.748
	Confidence Interval	(2-Sided) 95%; 1.96 to 3.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	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)
Description	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.
Time Frame	6 month treatment duration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Measure Participants	2223	2237
GGT	26 1.2%	86 3.8%
AST	8 0.4%	12 0.5%
ALT	13 0.6%	27 1.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	GGT
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Relative Risk
	Estimated Value	3.329
	Confidence Interval	(2-Sided) 95%; 2.156 to 5.141
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	AST
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3809
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Relative Risk
	Estimated Value	1.509
	Confidence Interval	(2-Sided) 95%; 0.618 to 3.684
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	ALT
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0264
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Relative Risk
	Estimated Value	2.089
	Confidence Interval	(2-Sided) 95%; 1.081 to 4.038
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2223	2237
GGT	-2.689 (0.591)	7.455 (0.592)
AST	-0.901 (0.239)	1.490 (0.239)
ALT	-1.151 (0.364)	5.213 (0.364)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	GGT
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.144
	Confidence Interval	(2-Sided) 95%; -11.51 to -8.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.697
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	AST
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.391
	Confidence Interval	(2-Sided) 95%; -2.94 to -1.84
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.281
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments	ALT
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.364
	Confidence Interval	(2-Sided) 95%; -7.20 to -5.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.428
	Estimation Comments

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Measure Participants	2185	2171
Least Squares Mean (Standard Error) [microgram (ug)/dL]	2.517 (1.158)	1.952 (1.161)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6795
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.565
	Confidence Interval	(2-Sided) 95%; -2.11 to 3.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.366
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Ferretin to Month 6/ET
Time Frame	Month 6/ET

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2185	2170
Least Squares Mean (Standard Error) [ug/dL]	-3.396 (2.224)	-1.990 (2.228)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5920
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.406
	Confidence Interval	(2-Sided) 95%; -6.55 to 3.74
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.624
	Estimation Comments

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2185	2171
Least Squares Mean (Standard Error) [mg/dL]	0.058 (0.032)	0.073 (0.032)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Celecoxib, Oral Diclofenac Plus Omeprazole
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6819
	Comments
	Method	ANCOVA
	Comments	Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.038
	Estimation Comments

16. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2047	2048
Number [participants]	2018 90.2%	2023 90.1%

17. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Celecoxib	Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo	Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Measure Participants	2047	2048
Number [participants]	82 3.7%	79 3.5%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Celecoxib		Oral Diclofenac Plus Omeprazole
Arm/Group Description	200 mg BID plus omeprazole placebo and diclofenac SR placebo		Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
All Cause Mortality
	Celecoxib		Oral Diclofenac Plus Omeprazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Celecoxib		Oral Diclofenac Plus Omeprazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/2223 (2.7%)		61/2237 (2.7%)
Blood and lymphatic system disorders
Normochromic normocytic anaemia	0/2223 (0%)		1/2237 (0%)
Cardiac disorders
Acute myocardial infarction	2/2223 (0.1%)		2/2237 (0.1%)
Angina unstable	1/2223 (0%)		0/2237 (0%)
Cardiogenic shock	1/2223 (0%)		0/2237 (0%)
Coronary artery stenosis	1/2223 (0%)		1/2237 (0%)
Myocardial infarction	1/2223 (0%)		0/2237 (0%)
Myocardial ischaemia	0/2223 (0%)		1/2237 (0%)
Ear and labyrinth disorders
Hypoacusis	1/2223 (0%)		0/2237 (0%)
Eye disorders
Glaucoma	0/2223 (0%)		1/2237 (0%)
Gastrointestinal disorders
Abdominal pain	1/2223 (0%)		1/2237 (0%)
Abdominal pain lower	0/2223 (0%)		1/2237 (0%)
Abdominal pain upper	0/2223 (0%)		1/2237 (0%)
Colitis	1/2223 (0%)		1/2237 (0%)
Constipation	0/2223 (0%)		2/2237 (0.1%)
Diarrhoea	0/2223 (0%)		2/2237 (0.1%)
Duodenal ulcer	2/2223 (0.1%)		0/2237 (0%)
Dyspepsia	0/2223 (0%)		1/2237 (0%)
Enteritis	1/2223 (0%)		0/2237 (0%)
Erosive oesophagitis	1/2223 (0%)		0/2237 (0%)
Gastric ulcer	2/2223 (0.1%)		2/2237 (0.1%)
Gastric ulcer haemorrhage	0/2223 (0%)		1/2237 (0%)
Gastritis	0/2223 (0%)		1/2237 (0%)
Gastritis erosive	0/2223 (0%)		1/2237 (0%)
Gastrointestinal haemorrhage	1/2223 (0%)		0/2237 (0%)
Inguinal hernia	0/2223 (0%)		1/2237 (0%)
Nausea	1/2223 (0%)		3/2237 (0.1%)
Reflux oesophagitis	1/2223 (0%)		0/2237 (0%)
Umbilical hernia	0/2223 (0%)		1/2237 (0%)
Vomiting	0/2223 (0%)		2/2237 (0.1%)
General disorders
Chest pain	1/2223 (0%)		0/2237 (0%)
Death	0/2223 (0%)		1/2237 (0%)
Disease progression	1/2223 (0%)		0/2237 (0%)
Pyrexia	3/2223 (0.1%)		1/2237 (0%)
Hepatobiliary disorders
Cholangitis	0/2223 (0%)		1/2237 (0%)
Cholecystitis acute	1/2223 (0%)		0/2237 (0%)
Cholelithiasis	2/2223 (0.1%)		2/2237 (0.1%)
Infections and infestations
Acute sinusitis	1/2223 (0%)		0/2237 (0%)
Appendicitis	1/2223 (0%)		0/2237 (0%)
Arthritis bacterial	0/2223 (0%)		2/2237 (0.1%)
Bronchopneumonia	0/2223 (0%)		2/2237 (0.1%)
Burn infection	1/2223 (0%)		0/2237 (0%)
Cellulitis	2/2223 (0.1%)		1/2237 (0%)
Chronic sinusitis	0/2223 (0%)		1/2237 (0%)
Device related infection	1/2223 (0%)		0/2237 (0%)
Enterocolitis infectious	0/2223 (0%)		1/2237 (0%)
Erysipelas	1/2223 (0%)		0/2237 (0%)
Groin abscess	0/2223 (0%)		1/2237 (0%)
Osteomyelitis	0/2223 (0%)		1/2237 (0%)
Pulmonary tuberculosis	1/2223 (0%)		0/2237 (0%)
Pyothorax	1/2223 (0%)		0/2237 (0%)
Urinary tract infection	1/2223 (0%)		2/2237 (0.1%)
Injury, poisoning and procedural complications
Ankle fracture	0/2223 (0%)		2/2237 (0.1%)
Comminuted fracture	0/2223 (0%)		1/2237 (0%)
Concussion	1/2223 (0%)		0/2237 (0%)
Eye burns	1/2223 (0%)		0/2237 (0%)
Fall	1/2223 (0%)		0/2237 (0%)
Femur fracture	1/2223 (0%)		0/2237 (0%)
Forearm fracture	0/2223 (0%)		2/2237 (0.1%)
Gun shot wound	0/2223 (0%)		1/2237 (0%)
Injury	1/2223 (0%)		1/2237 (0%)
Joint sprain	0/2223 (0%)		1/2237 (0%)
Lumbar vertebral fracture	1/2223 (0%)		0/2237 (0%)
Medical device complication	0/2223 (0%)		1/2237 (0%)
Meniscus lesion	1/2223 (0%)		1/2237 (0%)
Muscle strain	1/2223 (0%)		0/2237 (0%)
Radius fracture	0/2223 (0%)		1/2237 (0%)
Rib fracture	1/2223 (0%)		0/2237 (0%)
Road traffic accident	1/2223 (0%)		2/2237 (0.1%)
Spinal compression fracture	1/2223 (0%)		0/2237 (0%)
Thoracic vertebral fracture	0/2223 (0%)		1/2237 (0%)
Tibia fracture	0/2223 (0%)		1/2237 (0%)
Traumatic brain injury	0/2223 (0%)		1/2237 (0%)
Upper limb fracture	1/2223 (0%)		0/2237 (0%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/2223 (0%)		1/2237 (0%)
Hyperuricaemia	0/2223 (0%)		1/2237 (0%)
Hypoglycaemia	0/2223 (0%)		1/2237 (0%)
Hypokalaemia	1/2223 (0%)		1/2237 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/2223 (0%)		1/2237 (0%)
Bone pain	0/2223 (0%)		1/2237 (0%)
Chondropathy	1/2223 (0%)		0/2237 (0%)
Intervertebral disc protrusion	1/2223 (0%)		1/2237 (0%)
Muscular weakness	0/2223 (0%)		1/2237 (0%)
Myalgia	0/2223 (0%)		1/2237 (0%)
Osteoarthritis	4/2223 (0.2%)		4/2237 (0.2%)
Rheumatoid arthritis	0/2223 (0%)		1/2237 (0%)
Rotator cuff syndrome	0/2223 (0%)		1/2237 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	0/2223 (0%)		1/2237 (0%)
Basal cell carcinoma	0/2223 (0%)		1/2237 (0%)
Brain neoplasm	1/2223 (0%)		0/2237 (0%)
Breast cancer	0/2223 (0%)		1/2237 (0%)
Colon cancer	1/2223 (0%)		0/2237 (0%)
Endometrial cancer	0/2223 (0%)		1/2237 (0%)
Gastric adenoma	0/2223 (0%)		1/2237 (0%)
Hepatic neoplasm malignant	0/2223 (0%)		1/2237 (0%)
Leukaemia	1/2223 (0%)		0/2237 (0%)
Non-Hodgkin's lymphoma	1/2223 (0%)		0/2237 (0%)
Thyroid cancer	1/2223 (0%)		0/2237 (0%)
Nervous system disorders
Balance disorder	1/2223 (0%)		0/2237 (0%)
Carotid artery stenosis	0/2223 (0%)		1/2237 (0%)
Cerebral haemorrhage	1/2223 (0%)		0/2237 (0%)
Cerebrovascular accident	1/2223 (0%)		2/2237 (0.1%)
Dizziness	0/2223 (0%)		2/2237 (0.1%)
Dysarthria	1/2223 (0%)		0/2237 (0%)
Facial palsy	1/2223 (0%)		0/2237 (0%)
Headache	1/2223 (0%)		1/2237 (0%)
Hypoaesthesia	1/2223 (0%)		1/2237 (0%)
Ischaemic stroke	0/2223 (0%)		2/2237 (0.1%)
Sciatica	1/2223 (0%)		0/2237 (0%)
Transient ischaemic attack	2/2223 (0.1%)		0/2237 (0%)
Psychiatric disorders
Major depression	1/2223 (0%)		0/2237 (0%)
Suicide attempt	1/2223 (0%)		0/2237 (0%)
Renal and urinary disorders
Calculus urinary	0/2223 (0%)		1/2237 (0%)
Haematuria	0/2223 (0%)		1/2237 (0%)
Renal failure	0/2223 (0%)		1/2237 (0%)
Renal failure acute	0/2223 (0%)		1/2237 (0%)
Tubulointerstitial nephritis	0/2223 (0%)		1/2237 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/2223 (0%)		1/2237 (0%)
Ovarian cyst ruptured	1/2223 (0%)		0/2237 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/2223 (0%)		0/2237 (0%)
Acute respiratory failure	1/2223 (0%)		0/2237 (0%)
Bronchitis chronic	0/2223 (0%)		1/2237 (0%)
Dyspnoea exertional	0/2223 (0%)		1/2237 (0%)
Interstitial lung disease	0/2223 (0%)		1/2237 (0%)
Nasal congestion	0/2223 (0%)		1/2237 (0%)
Pneumothorax	0/2223 (0%)		1/2237 (0%)
Pulmonary embolism	2/2223 (0.1%)		0/2237 (0%)
Skin and subcutaneous tissue disorders
Hypoaesthesia facial	1/2223 (0%)		0/2237 (0%)
Surgical and medical procedures
Carpal tunnel decompression	1/2223 (0%)		0/2237 (0%)
Hip arthroplasty	1/2223 (0%)		0/2237 (0%)
Open reduction of fracture	1/2223 (0%)		0/2237 (0%)
Prolapse repair	1/2223 (0%)		0/2237 (0%)
Rectocele repair	0/2223 (0%)		1/2237 (0%)
Vascular disorders
Deep vein thrombosis	1/2223 (0%)		0/2237 (0%)
Embolism	1/2223 (0%)		0/2237 (0%)
Hypertension	0/2223 (0%)		1/2237 (0%)
Thrombophlebitis superficial	1/2223 (0%)		0/2237 (0%)
Other (Not Including Serious) Adverse Events
	Celecoxib		Oral Diclofenac Plus Omeprazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	530/2223 (23.8%)		669/2237 (29.9%)
Gastrointestinal disorders
Abdominal pain upper	96/2223 (4.3%)		133/2237 (5.9%)
Diarrhoea	79/2223 (3.6%)		168/2237 (7.5%)
Dyspepsia	137/2223 (6.2%)		111/2237 (5%)
Gastritis	32/2223 (1.4%)		44/2237 (2%)
Nausea	33/2223 (1.5%)		66/2237 (3%)
General disorders
Oedema peripheral	46/2223 (2.1%)		67/2237 (3%)
Infections and infestations
Nasopharyngitis	55/2223 (2.5%)		46/2237 (2.1%)
Investigations
Haemoglobin decreased	27/2223 (1.2%)		72/2237 (3.2%)
Nervous system disorders
Headache	66/2223 (3%)		48/2237 (2.1%)
Vascular disorders
Hypertension	76/2223 (3.4%)		84/2237 (3.8%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.