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Trial record 6 of 593 for:    Celecoxib

European Celecoxib Trial in Primary Breast Cancer (REACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429427
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Celecoxib
Other: Placebo
Enrollment 2639
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 1763 876
Completed 1392 697
Not Completed 371 179
Reason Not Completed
Adverse Event             220             92
Protocol Violation             10             6
Lost to Follow-up             15             6
Withdrawal by Subject             64             34
Other             62             41
Arm/Group Title Celecoxib Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 1763 876 2639
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 1763 participants 876 participants 2639 participants
55.2
(48.7 to 62.6)
55.3
(48.6 to 63.0)
55.2
(48.6 to 62.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1763 participants 876 participants 2639 participants
Female
1763
 100.0%
876
 100.0%
2639
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 1763 participants 876 participants 2639 participants
Caucasian
1689
  95.8%
848
  96.8%
2537
  96.1%
Asian
29
   1.6%
8
   0.9%
37
   1.4%
Other
21
   1.2%
10
   1.1%
31
   1.2%
Black Caribbean
13
   0.7%
4
   0.5%
17
   0.6%
Black African
8
   0.5%
4
   0.5%
12
   0.5%
Black Other
3
   0.2%
2
   0.2%
5
   0.2%
1.Primary Outcome
Title Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients.
Hide Description 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)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1763 876
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2 Year DFS rate
91
(90 to 93)
90
(87 to 92)
5 Year DFS rate
84
(82 to 86)
83
(81 to 86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method Log Rank
Comments Analysis stratified by oestrogen receptor status and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.80 to 1.17
Estimation Comments Analysis stratified by oestrogen receptor status and country.
2.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1763 876
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2 Year
97
(96 to 97)
96
(95 to 97)
5 Year
90
(89 to 92)
91
(88 to 92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method Log Rank
Comments Analysis is stratified for oestrogen receptor status and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.76 to 1.22
Estimation Comments Analysis is stratified for oestrogen receptor status and country.
3.Secondary Outcome
Title Number of Participants With Incidence of Second Primary Breast Cancers
Hide Description Any malignant contralateral breast disease will be included and recorded as a second primary
Time Frame From randomisation until a second primary breast cancer is diagnosed. Patients will be followed up to 10 years.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1763 876
Measure Type: Count of Participants
Unit of Measure: Participants
19
   1.1%
12
   1.4%
4.Secondary Outcome
Title Cardiovascular Mortality
Hide Description Number of deaths recorded as having cardiovascular involvement are reported by treatment group.
Time Frame Patients are followed up to 10 years, any deaths within this timeframe with cardiovascular involvement reported are included in the analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1755 868
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.3%
5
   0.6%
Time Frame From the time of randomisation until 30 days after the discontinuation of celecoxib/placebo (i.e. 2 years or sooner if patient discontinued early).
Adverse Event Reporting Description Only adverse events classed as grade 2 or above were collected. Adverse Events and SAEs were assessed in the Safety Population and All-Cause Mortality was assessed for all enrolled participants
 
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description

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.

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

All-Cause Mortality
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   203/1763 (11.51%)      104/876 (11.87%)    
Hide Serious Adverse Events
Celecoxib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   148/1755 (8.43%)      64/868 (7.37%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/1755 (0.06%)  1 2/868 (0.23%)  2
Neutropenia * 1  0/1755 (0.00%)  0 2/868 (0.23%)  2
Thrombocytopenia * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Thrombocytopenic purpura * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Cardiac disorders     
Acute cardiac event * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Aortic valve incompetence * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Arrhythmia * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Atrial fibrillation * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Cardiac failure * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Cardiac tamponade * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Cardiomegaly * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Cardiomyopathy * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Chest pain - cardiac * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Pulmonary oedema * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Tachycardia * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Congenital, familial and genetic disorders     
Ventricular septal defect * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Ear and labyrinth disorders     
Deafness * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Eye disorders     
Retinal detachment * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Gastrointestinal disorders     
Gastrointestinal disorder * 1  7/1755 (0.40%)  7 2/868 (0.23%)  2
Small intestinal obstruction * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Abdominal pain * 1  6/1755 (0.34%)  6 0/868 (0.00%)  0
Abdominal pain upper * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Colitis * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Diarrhoea * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Diverticulitis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Diverticulum * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Gastric ulcer * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Gastritis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Pancreatitis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Rectal haemorrhage * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Vomiting * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
General disorders     
Chest pain * 1  6/1755 (0.34%)  6 2/868 (0.23%)  2
Condition aggravated * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Death * 1  3/1755 (0.17%)  3 1/868 (0.12%)  1
Fibrosis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Malaise * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Oedema peripheral * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Perforated ulcer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Pyrexia * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Suprapubic pain * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Cholelithiasis * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Hepatic function abnormal * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Immune system disorders     
Hypersensitivity * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Infections and infestations     
Abscess * 1  3/1755 (0.17%)  3 1/868 (0.12%)  1
Appendicitis * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Cellulitis * 1  7/1755 (0.40%)  9 2/868 (0.23%)  2
Infection * 1  6/1755 (0.34%)  9 1/868 (0.12%)  1
Lower respiratory tract infection * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Mastitis * 1  3/1755 (0.17%)  3 2/868 (0.23%)  2
Ophthalmic herpes zoster * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Pneumonia * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Sepsis * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Urinary tract infection * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Uterine infection * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Wound infection * 1  2/1755 (0.11%)  2 1/868 (0.12%)  1
Injury, poisoning and procedural complications     
Fall * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Head injury * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Overdose * 1  2/1755 (0.11%)  2 1/868 (0.12%)  1
Post procedural complication * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Postoperative wound complication * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Road traffic accident * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Seroma * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Thermal burn * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Wound necrosis * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Investigations     
Hepatic enzyme increased * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Ankle fracture * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Arthralgia * 1  4/1755 (0.23%)  5 1/868 (0.12%)  1
Back pain * 1  2/1755 (0.11%)  2 2/868 (0.23%)  3
Bone pain * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Clavicle fracture * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Femur fracture * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Foot fracture * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Fracture * 1  3/1755 (0.17%)  3 0/868 (0.00%)  0
Humerus fracture * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Intervertebral disc degeneration * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Intervertebral disc protrusion * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Lower limb fracture * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Musculoskeletal pain * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Pain in extremity * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Radius fracture * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Rib fracture * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Spinal fracture * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Tibia fracture * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Upper limb fracture * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma * 1  2/1755 (0.11%)  2 1/868 (0.12%)  1
Adenocarcinoma of colon * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Adenoid cystic carcinoma * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Adrenal adenoma * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Basal cell carcinoma * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Benign ovarian tumour * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Breast cancer * 1  2/1755 (0.11%)  2 1/868 (0.12%)  1
Breast cancer recurrent * 1  3/1755 (0.17%)  3 0/868 (0.00%)  0
Colon cancer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Gallbladder cancer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Lung neoplasm malignant * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Malignant melanoma * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Malignant neoplasm progression * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Metastases to central nervous system * 1  3/1755 (0.17%)  3 0/868 (0.00%)  0
Metastases to liver * 1  2/1755 (0.11%)  2 2/868 (0.23%)  2
Metastases to lung * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Metastasis * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Neoplasm malignant * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Ovarian cancer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Pancreatic carcinoma * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Rectal cancer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Second primary malignancy * 1  5/1755 (0.28%)  5 2/868 (0.23%)  2
Vulval cancer * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Nervous system disorders     
Amnesia * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Cerebellar infarction * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Cerebrovascular accident * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Encephalopathy * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Nervous system disorder * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Neurological symptom * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Peripheral sensory neuropathy * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Seizure * 1  1/1755 (0.06%)  1 3/868 (0.35%)  3
Subarachnoid haemorrhage * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Syncope * 1  0/1755 (0.00%)  0 2/868 (0.23%)  2
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  3/1755 (0.17%)  4 4/868 (0.46%)  4
Psychiatric disorders     
Depression * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Psychiatric symptom * 1  3/1755 (0.17%)  3 0/868 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Renal colic * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Reproductive system and breast disorders     
Adnexal torsion * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Breast necrosis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Breast pain * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Endometrial hyperplasia * 1  1/1755 (0.06%)  1 2/868 (0.23%)  2
Ovarian cyst * 1  2/1755 (0.11%)  2 2/868 (0.23%)  2
Vaginal haemorrhage * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Alveolitis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Dyspnoea * 1  8/1755 (0.46%)  9 0/868 (0.00%)  0
Emphysema * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Pleural effusion * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Productive cough * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Pulmonary embolism * 1  5/1755 (0.28%)  5 0/868 (0.00%)  0
Respiratory disorder * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erysipelas * 1  2/1755 (0.11%)  2 0/868 (0.00%)  0
Erythema * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Rash * 1  3/1755 (0.17%)  3 0/868 (0.00%)  0
Skin lesion * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Swelling of eyelid * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Urticaria * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Surgical and medical procedures     
Abortion induced * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Breast reconstruction * 1  3/1755 (0.17%)  3 2/868 (0.23%)  4
Cholecystectomy * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Hysterosalpingo-oophorectomy * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Knee arthroplasty * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Oophorectomy bilateral * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Surgery * 1  0/1755 (0.00%)  0 2/868 (0.23%)  2
Vascular disorders     
Deep vein thrombosis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Epistaxis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Haematemesis * 1  1/1755 (0.06%)  1 0/868 (0.00%)  0
Haematoma * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Haemorrhage * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Hypertension * 1  0/1755 (0.00%)  0 1/868 (0.12%)  1
Myocardial infarction * 1  1/1755 (0.06%)  1 1/868 (0.12%)  1
Embolism * 1  2/1755 (0.11%)  2 1/868 (0.12%)  1
1
Term from vocabulary, MedDRA 14.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   298/1755 (16.98%)      151/868 (17.40%)    
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  128/1755 (7.29%)  85/868 (9.79%) 
Reproductive system and breast disorders     
Hot flush * 2  106/1755 (6.04%)  54/868 (6.22%) 
Vascular disorders     
Hypertension * 2  178/1755 (10.14%)  72/868 (8.29%) 
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Charles Coombes
Organization: Imperial College London
Phone: +44 20 7594 2135
EMail: c.coombes@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02429427    
Other Study ID Numbers: C/20/01
First Submitted: April 15, 2015
First Posted: April 29, 2015
Results First Submitted: May 26, 2020
Results First Posted: June 23, 2020
Last Update Posted: June 23, 2020