Trial Outcomes & Findings for European Celecoxib Trial in Primary Breast Cancer (NCT NCT02429427)

NCT ID: NCT02429427

Last Updated: 2020-06-23

Results Overview

From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2639 participants
• Primary outcome timeframe: Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years
• Results posted on: 2020-06-23

Participant Flow

Participant milestones

Measure	Celecoxib Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Overall Study STARTED	1763	876
Overall Study COMPLETED	1392	697
Overall Study NOT COMPLETED	371	179

Reasons for withdrawal

Measure	Celecoxib Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Overall Study Adverse Event	220	92
Overall Study Protocol Violation	10	6
Overall Study Lost to Follow-up	15	6
Overall Study Withdrawal by Subject	64	34
Overall Study Other	62	41

Baseline Characteristics

European Celecoxib Trial in Primary Breast Cancer

Baseline characteristics by cohort

Measure	Celecoxib n=1763 Participants Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=876 Participants Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food	Total n=2639 Participants Total of all reporting groups
Age, Continuous	55.2 years n=5 Participants	55.3 years n=7 Participants	55.2 years n=5 Participants
Sex: Female, Male Female	1763 Participants n=5 Participants	876 Participants n=7 Participants	2639 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	1689 Participants n=5 Participants	848 Participants n=7 Participants	2537 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	29 Participants n=5 Participants	8 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black Caribbean	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black African	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years

Population: Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol.

From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)

Outcome measures

Measure	Celecoxib n=1763 Participants Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=876 Participants Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. 2 Year DFS rate	91 Percentage of participants Interval 90.0 to 93.0	90 Percentage of participants Interval 87.0 to 92.0
Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. 5 Year DFS rate	84 Percentage of participants Interval 82.0 to 86.0	83 Percentage of participants Interval 81.0 to 86.0

SECONDARY outcome

Timeframe: Date of randomisation until the date of death from any cause or censored at the date the patient was last seen alive, this will be assessed at 2 and 5 years

Population: Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol.

First local recurrence and first distant recurrence will be recorded on separate parts of the CRF. In the event of local progression, all patients must be followed up for distant recurrence, second malignancy and survival. Similarly in the case of second malignancy, the appropriate CRF should be completed and patients should REACT Protocol, Version 39, dated 01.11.2016 Page 34 of 48 continue to be followed for disease progression and where possible the relation of any subsequent disease progression and/or death due to the primary or second cancer should be established.

Outcome measures

Measure	Celecoxib n=1763 Participants Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=876 Participants Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Overall Survival 2 Year	97 Percentage of participants Interval 96.0 to 97.0	96 Percentage of participants Interval 95.0 to 97.0
Overall Survival 5 Year	90 Percentage of participants Interval 89.0 to 92.0	91 Percentage of participants Interval 88.0 to 92.0

SECONDARY outcome

Timeframe: From randomisation until a second primary breast cancer is diagnosed. Patients will be followed up to 10 years.

Population: Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol.

Any malignant contralateral breast disease will be included and recorded as a second primary

Outcome measures

Measure	Celecoxib n=1763 Participants Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=876 Participants Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Number of Participants With Incidence of Second Primary Breast Cancers	19 Participants	12 Participants

SECONDARY outcome

Timeframe: Patients are followed up to 10 years, any deaths within this timeframe with cardiovascular involvement reported are included in the analysis.

Population: Safety population: This population includes all patients who start treatment, patients will be analysed by the treatment they received regardless of the group they were allocated to.

Number of deaths recorded as having cardiovascular involvement are reported by treatment group.

Outcome measures

Measure	Celecoxib n=1755 Participants Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=868 Participants Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Cardiovascular Mortality	6 Participants	5 Participants

Adverse Events

Celecoxib

Serious events: 148 serious events

Other events: 298 other events

Deaths: 203 deaths

Placebo

Serious events: 64 serious events

Other events: 151 other events

Deaths: 104 deaths

Serious adverse events

Measure	Celecoxib n=1755 participants at risk Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=868 participants at risk Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Vascular disorders Epistaxis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Haematemesis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Haematoma	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Blood and lymphatic system disorders Anaemia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Blood and lymphatic system disorders Neutropenia	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Blood and lymphatic system disorders Thrombocytopenic purpura	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Acute cardiac event	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Aortic valve incompetence	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Arrhythmia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Atrial fibrillation	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Cardiac failure	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Cardiac tamponade	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Cardiomegaly	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Cardiomyopathy	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Chest pain - cardiac	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Pulmonary oedema	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Cardiac disorders Tachycardia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Ear and labyrinth disorders Deafness	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Eye disorders Retinal detachment	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Gastrointestinal disorder	0.40% 7/1755 • Number of events 7 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Small intestinal obstruction	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Abdominal pain	0.34% 6/1755 • Number of events 6 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Colitis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Diarrhoea	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Diverticulitis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Diverticulum	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Gastric ulcer	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Gastritis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Pancreatitis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Rectal haemorrhage	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Gastrointestinal disorders Vomiting	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Chest pain	0.34% 6/1755 • Number of events 6 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Condition aggravated	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Death	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Fibrosis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Malaise	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Oedema peripheral	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Perforated ulcer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Pyrexia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
General disorders Suprapubic pain	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Hepatobiliary disorders Cholecystitis	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Hepatobiliary disorders Cholelithiasis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Hepatobiliary disorders Hepatic function abnormal	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Immune system disorders Hypersensitivity	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Abscess	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Appendicitis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Cellulitis	0.40% 7/1755 • Number of events 9 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Infection	0.34% 6/1755 • Number of events 9 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Lower respiratory tract infection	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Mastitis	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Pneumonia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Sepsis	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Urinary tract infection	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Uterine infection	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Infections and infestations Wound infection	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Fall	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Head injury	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Overdose	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Post procedural complication	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Postoperative wound complication	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Seroma	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Investigations Hepatic enzyme increased	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Ankle fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Arthralgia	0.23% 4/1755 • Number of events 5 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Back pain	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Bone pain	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Clavicle fracture	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Femur fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Foot fracture	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Fracture	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Humerus fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Lower limb fracture	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Radius fracture	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Rib fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Spinal fracture	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Tibia fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Musculoskeletal and connective tissue disorders Upper limb fracture	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.28% 5/1755 • Number of events 5 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Amnesia	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Cerebellar infarction	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Cerebrovascular accident	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Encephalopathy	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Nervous system disorder	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Neurological symptom	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Peripheral sensory neuropathy	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Seizure	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.35% 3/868 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Nervous system disorders Syncope	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Pregnancy, puerperium and perinatal conditions Pregnancy	0.17% 3/1755 • Number of events 4 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.46% 4/868 • Number of events 4 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Psychiatric disorders Depression	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Psychiatric disorders Psychiatric symptom	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Renal and urinary disorders Nephrolithiasis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Renal and urinary disorders Renal colic	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Adnexal torsion	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Breast necrosis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Breast pain	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Endometrial hyperplasia	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Ovarian cyst	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Vaginal haemorrhage	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Alveolitis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 8/1755 • Number of events 9 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Productive cough	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.28% 5/1755 • Number of events 5 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Erysipelas	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Erythema	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Rash	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Swelling of eyelid	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Skin and subcutaneous tissue disorders Urticaria	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Abortion induced	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Breast reconstruction	0.17% 3/1755 • Number of events 3 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 4 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Cholecystectomy	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Knee arthroplasty	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Oophorectomy bilateral	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Surgical and medical procedures Surgery	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.23% 2/868 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Deep vein thrombosis	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.00% 0/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Haemorrhage	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Hypertension	0.00% 0/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Myocardial infarction	0.06% 1/1755 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Embolism	0.11% 2/1755 • Number of events 2 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	0.12% 1/868 • Number of events 1 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants

Other adverse events

Measure	Celecoxib n=1755 participants at risk Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.	Placebo n=868 participants at risk Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 128/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	9.8% 85/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Reproductive system and breast disorders Hot flush	6.0% 106/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	6.2% 54/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
Vascular disorders Hypertension	10.1% 178/1755 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants	8.3% 72/868 • From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early). Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants

Additional Information

Prof Charles Coombes

Imperial College London

Phone: +44 20 7594 2135

Email: c.coombes@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place