Trial Outcomes & Findings for Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen (NCT NCT00038103)
NCT ID: NCT00038103
Last Updated: 2010-02-25
Results Overview
Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)
Results posted on
2010-02-25
Participant Flow
2 subjects in the exemestane arm were never treated. One subject refused to be treated having originally consented to participate in this study and the other, reason for not starting treatment was unknown
Participant milestones
| Measure |
Exemestane (Exemestane Alone)
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
|
Overall Study
End of Treatment
|
53
|
56
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
55
|
56
|
Reasons for withdrawal
| Measure |
Exemestane (Exemestane Alone)
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
48
|
41
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Randomized/never treated
|
2
|
0
|
Baseline Characteristics
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
Baseline characteristics by cohort
| Measure |
Exemestane (Exemestane Alone)
n=55 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=56 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 50 years
|
20.0 Participants
n=5 Participants
|
16.0 Participants
n=7 Participants
|
36.0 Participants
n=5 Participants
|
|
Age, Customized
50-64 years
|
20.0 Participants
n=5 Participants
|
27.0 Participants
n=7 Participants
|
47.0 Participants
n=5 Participants
|
|
Age, Customized
65-79 years
|
15.0 Participants
n=5 Participants
|
12.0 Participants
n=7 Participants
|
27.0 Participants
n=5 Participants
|
|
Age, Customized
=> 80 years
|
0.0 Participants
n=5 Participants
|
1.0 Participants
n=7 Participants
|
1.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)Population: Evaluable population
Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=49 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=51 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Number of Subjects With Clinical Benefit
|
24 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLVPopulation: Evaluable population
Objective tumor response includes subjects with CR or PR according to RECIST.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=49 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=51 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Number of Subjects With Objective Response
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLVPopulation: Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.
Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=24 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=24 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Duration of Clinical Benefit
|
49.1 weeks
Interval 37.0 to 85.0
|
96.6 weeks
Interval 37.0 to 147.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLVPopulation: Evaluable population. Number of participants analyzed = number of subjects with objective response.
Time from the first objective documentation of response until the first objective documentation of tumor progression.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=11 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=12 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Duration of Objective Response (in Subjects With CR or PR)
|
32.7 weeks
Interval 23.1 to 68.9
|
40.1 weeks
Interval 28.3 to 169.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLVPopulation: Evaluable population. Number of participants analyzed = number of subjects with long-term SD.
Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=13 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=12 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Duration of Long-Term SD
|
52.9 weeks
Interval 36.6 to 110.0
|
109.7 weeks
Interval 36.6 to 147.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLVPopulation: Evaluable population
Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=49 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=51 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Time to Tumor Progression
|
20 weeks
Interval 9.4 to 36.6
|
23.4 weeks
Interval 16.3 to 36.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLVPopulation: Evaluable population
Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=49 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=51 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Time to Treatment Failure
|
18.1 Weeks
Interval 9.3 to 36.6
|
20.4 Weeks
Interval 14.9 to 34.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or deathPopulation: Evaluable population
Time from randomization to date of death (any cause).
Outcome measures
| Measure |
Exemestane (Exemestane Alone)
n=49 Participants
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
n=51 Participants
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Survival
|
74.4 weeks
Interval 57.7 to 101.4
|
73.9 weeks
Interval 52.3 to 106.7
|
Adverse Events
Exemestane (Exemestane Alone)
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
Combination (Exemestane + Celecoxib)
Serious events: 14 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane (Exemestane Alone)
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Hepatobiliary disorders
Jaundice
|
3.8%
2/53
|
0.00%
0/56
|
|
General disorders
Pain
|
1.9%
1/53
|
1.8%
1/56
|
|
Reproductive system and breast disorders
Post procedural complication
|
1.9%
1/53
|
0.00%
0/56
|
|
General disorders
Death
|
1.9%
1/53
|
1.8%
1/56
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53
|
0.00%
0/56
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/53
|
0.00%
0/56
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53
|
0.00%
0/56
|
|
General disorders
General physical health deterioration
|
1.9%
1/53
|
1.8%
1/56
|
|
Nervous system disorders
Asterixis
|
1.9%
1/53
|
0.00%
0/56
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.9%
1/53
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.9%
1/53
|
0.00%
0/56
|
|
General disorders
Gait Disturbance
|
1.9%
1/53
|
1.8%
1/56
|
|
Psychiatric disorders
Disorientation
|
1.9%
1/53
|
0.00%
0/56
|
|
General disorders
Asthenia
|
3.8%
2/53
|
0.00%
0/56
|
|
Psychiatric disorders
Dizziness
|
1.9%
1/53
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
1.9%
1/53
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
2/53
|
5.4%
3/56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/53
|
0.00%
0/56
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.9%
1/53
|
0.00%
0/56
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/53
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/53
|
1.8%
1/56
|
|
Nervous system disorders
Miller Fisher Syndrome
|
0.00%
0/53
|
1.8%
1/56
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/53
|
1.8%
1/56
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53
|
1.8%
1/56
|
|
General disorders
Fatigue
|
0.00%
0/53
|
1.8%
1/56
|
|
Nervous system disorders
Paresis
|
0.00%
0/53
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/53
|
1.8%
1/56
|
|
General disorders
Back Pain
|
0.00%
0/53
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/53
|
1.8%
1/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/53
|
1.8%
1/56
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/53
|
1.8%
1/56
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/53
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Wrist Fracture
|
0.00%
0/53
|
1.8%
1/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/53
|
1.8%
1/56
|
Other adverse events
| Measure |
Exemestane (Exemestane Alone)
oral dose exemestane taken with food (25 mg tablet once daily)
|
Combination (Exemestane + Celecoxib)
oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/53
|
0.00%
0/53
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/53
|
1.9%
1/53
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/53
|
5.7%
3/53
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
2/53
|
5.7%
3/53
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Cheilitis
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Constipation
|
7.5%
4/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
3/53
|
9.4%
5/53
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.9%
1/53
|
1.9%
1/53
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/53
|
3.8%
2/53
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Nausea
|
9.4%
5/53
|
5.7%
3/53
|
|
Gastrointestinal disorders
Odynophagia
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Oesophagitis
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Peptic ulcer
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/53
|
0.00%
0/53
|
|
Gastrointestinal disorders
Vomiting
|
15.1%
8/53
|
3.8%
2/53
|
|
General disorders
Asthenia
|
7.5%
4/53
|
11.3%
6/53
|
|
General disorders
Axillary pain
|
1.9%
1/53
|
0.00%
0/53
|
|
General disorders
Chest pain
|
3.8%
2/53
|
3.8%
2/53
|
|
General disorders
Death
|
1.9%
1/53
|
0.00%
0/53
|
|
General disorders
Fatigue
|
7.5%
4/53
|
5.7%
3/53
|
|
General disorders
Gait disturbance
|
3.8%
2/53
|
3.8%
2/53
|
|
General disorders
General physical health deterioration
|
1.9%
1/53
|
1.9%
1/53
|
|
General disorders
Inflammation
|
1.9%
1/53
|
0.00%
0/53
|
|
General disorders
Oedema
|
1.9%
1/53
|
0.00%
0/53
|
|
General disorders
Oedema peripheral
|
3.8%
2/53
|
3.8%
2/53
|
|
General disorders
Pain
|
3.8%
2/53
|
3.8%
2/53
|
|
General disorders
Pyrexia
|
1.9%
1/53
|
0.00%
0/53
|
|
General disorders
Ulcer haemorrhage
|
1.9%
1/53
|
0.00%
0/53
|
|
Hepatobiliary disorders
Jaundice
|
3.8%
2/53
|
1.9%
1/53
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/53
|
0.00%
0/53
|
|
Infections and infestations
Fungal infection
|
1.9%
1/53
|
0.00%
0/53
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/53
|
0.00%
0/53
|
|
Infections and infestations
Lymphangitis
|
1.9%
1/53
|
0.00%
0/53
|
|
Infections and infestations
Respiratory tract infection
|
3.8%
2/53
|
0.00%
0/53
|
|
Infections and infestations
Sinusitis
|
1.9%
1/53
|
1.9%
1/53
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53
|
1.9%
1/53
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53
|
9.4%
5/53
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.9%
1/53
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Medical device complication
|
1.9%
1/53
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.9%
1/53
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Wound
|
1.9%
1/53
|
0.00%
0/53
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/53
|
1.9%
1/53
|
|
Investigations
Aspartate aminotransferase
|
1.9%
1/53
|
1.9%
1/53
|
|
Investigations
Blood alkaline phosphatase
|
3.8%
2/53
|
0.00%
0/53
|
|
Investigations
Blood alkaline phosphatase increased
|
3.8%
2/53
|
0.00%
0/53
|
|
Investigations
Gamma-glutamyltransferase
|
1.9%
1/53
|
1.9%
1/53
|
|
Investigations
Low density lipoprotein
|
1.9%
1/53
|
0.00%
0/53
|
|
Investigations
Neutrophil count decreased
|
1.9%
1/53
|
0.00%
0/53
|
|
Investigations
Platelet count decreased
|
1.9%
1/53
|
0.00%
0/53
|
|
Investigations
Weight decreased
|
3.8%
2/53
|
1.9%
1/53
|
|
Investigations
Weight increased
|
3.8%
2/53
|
0.00%
0/53
|
|
Investigations
White blood cell count decreased
|
1.9%
1/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Anorexia
|
13.2%
7/53
|
5.7%
3/53
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
1/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.8%
2/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
3/53
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.8%
2/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.9%
1/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.5%
4/53
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/53
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
5/53
|
11.3%
6/53
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.1%
8/53
|
18.9%
10/53
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
2/53
|
9.4%
5/53
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.9%
1/53
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/53
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/53
|
3.8%
2/53
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
3/53
|
3.8%
2/53
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.2%
7/53
|
9.4%
5/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.8%
2/53
|
0.00%
0/53
|
|
Nervous system disorders
Asterixis
|
1.9%
1/53
|
0.00%
0/53
|
|
Nervous system disorders
Ataxia
|
1.9%
1/53
|
0.00%
0/53
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53
|
0.00%
0/53
|
|
Nervous system disorders
Headache
|
9.4%
5/53
|
7.5%
4/53
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/53
|
1.9%
1/53
|
|
Nervous system disorders
Paraesthesia
|
3.8%
2/53
|
3.8%
2/53
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
1/53
|
5.7%
3/53
|
|
Nervous system disorders
Peroneal nerve palsy
|
1.9%
1/53
|
0.00%
0/53
|
|
Nervous system disorders
Sensory loss
|
1.9%
1/53
|
0.00%
0/53
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53
|
0.00%
0/53
|
|
Psychiatric disorders
Confusional state
|
1.9%
1/53
|
0.00%
0/53
|
|
Psychiatric disorders
Disorientation
|
1.9%
1/53
|
0.00%
0/53
|
|
Psychiatric disorders
Insomnia
|
5.7%
3/53
|
1.9%
1/53
|
|
Renal and urinary disorders
Dysuria
|
3.8%
2/53
|
0.00%
0/53
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
3/53
|
0.00%
0/53
|
|
Renal and urinary disorders
Pyuria
|
1.9%
1/53
|
0.00%
0/53
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
1/53
|
0.00%
0/53
|
|
Reproductive system and breast disorders
Breast pain
|
1.9%
1/53
|
3.8%
2/53
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/53
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
1/53
|
0.00%
0/53
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.8%
2/53
|
0.00%
0/53
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.9%
1/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
9/53
|
7.5%
4/53
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.8%
2/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
4/53
|
13.2%
7/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
2/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.9%
1/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/53
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/53
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
1/53
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
2/53
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
3/53
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
3/53
|
3.8%
2/53
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/53
|
1.9%
1/53
|
|
Vascular disorders
Hot flush
|
11.3%
6/53
|
15.1%
8/53
|
|
Vascular disorders
Hypertension
|
1.9%
1/53
|
3.8%
2/53
|
|
Vascular disorders
Lymphoedema
|
1.9%
1/53
|
0.00%
0/53
|
|
Vascular disorders
Pallor
|
1.9%
1/53
|
1.9%
1/53
|
|
Vascular disorders
Phlebitis
|
1.9%
1/53
|
0.00%
0/53
|
|
Vascular disorders
Vasodilatation
|
1.9%
1/53
|
0.00%
0/53
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53
|
3.8%
2/53
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/53
|
1.9%
1/53
|
|
Eye disorders
Visual impairment
|
0.00%
0/53
|
1.9%
1/53
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/53
|
1.9%
1/53
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/53
|
1.9%
1/53
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/53
|
1.9%
1/53
|
|
General disorders
Malaise
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53
|
5.7%
3/53
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Ear infection
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Influenza
|
0.00%
0/53
|
3.8%
2/53
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/53
|
3.8%
2/53
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Tooth infection
|
0.00%
0/53
|
1.9%
1/53
|
|
Infections and infestations
Tracheitis
|
0.00%
0/53
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/53
|
1.9%
1/53
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/53
|
1.9%
1/53
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/53
|
1.9%
1/53
|
|
Investigations
Pulse pressure increased
|
0.00%
0/53
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/53
|
3.8%
2/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/53
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/53
|
1.9%
1/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/53
|
1.9%
1/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Miller Fisher syndrome
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Paresis
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/53
|
1.9%
1/53
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53
|
3.8%
2/53
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/53
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/53
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/53
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/53
|
3.8%
2/53
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/53
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/53
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/53
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/53
|
1.9%
1/53
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/53
|
1.9%
1/53
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/53
|
1.9%
1/53
|
|
Vascular disorders
Hypotension
|
0.00%
0/53
|
1.9%
1/53
|
|
Vascular disorders
Varicose vein
|
0.00%
0/53
|
1.9%
1/53
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/53
|
3.8%
2/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER