Trial Outcomes & Findings for Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer (NCT NCT00143390)
NCT ID: NCT00143390
Last Updated: 2012-01-25
Results Overview
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
298 participants
Primary outcome timeframe
Up to 2008 days of the treatment
Results posted on
2012-01-25
Participant Flow
Participant milestones
| Measure |
Exemestane
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
149
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
149
|
149
|
Reasons for withdrawal
| Measure |
Exemestane
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Not meeting entry criteria
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Progressive disease
|
119
|
115
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Study termination
|
10
|
15
|
|
Overall Study
Adverse Event
|
9
|
8
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
Baseline characteristics by cohort
| Measure |
Exemestane
n=149 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=149 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years old
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
45-64 years old
|
86 participants
n=5 Participants
|
88 participants
n=7 Participants
|
174 participants
n=5 Participants
|
|
Age, Customized
>=65 years old
|
61 participants
n=5 Participants
|
61 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Outcome measures
| Measure |
Exemestane
n=147 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=145 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Time to Progression (TTP) - Expert Evaluation Committee Assessment
|
13.8 months
Interval 10.8 to 16.5
|
11.1 months
Interval 10.8 to 16.6
|
SECONDARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Outcome measures
| Measure |
Exemestane
n=147 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=145 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Time to Progression (TTP) - Investigators Assessment
|
13.8 months
Interval 10.0 to 16.6
|
13.7 months
Interval 10.9 to 16.6
|
SECONDARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.
Outcome measures
| Measure |
Exemestane
n=132 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=128 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Number of Participants With Objective Response - Investigators Assessment
CR
|
2 participants
|
3 participants
|
|
Number of Participants With Objective Response - Investigators Assessment
PR
|
56 participants
|
47 participants
|
|
Number of Participants With Objective Response - Investigators Assessment
Objective Response (CR + PR)
|
58 participants
|
50 participants
|
SECONDARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.
Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD
Outcome measures
| Measure |
Exemestane
n=132 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=128 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Number of Participants With Clinical Benefit - Investigator Assessment
CR
|
2 participants
|
3 participants
|
|
Number of Participants With Clinical Benefit - Investigator Assessment
PR
|
56 participants
|
47 participants
|
|
Number of Participants With Clinical Benefit - Investigator Assessment
long-term SD
|
41 participants
|
49 participants
|
|
Number of Participants With Clinical Benefit - Investigator Assessment
Clinical Benefit (CR+PR+long-term SD)
|
99 participants
|
99 participants
|
SECONDARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.
OS is defined as time from the date of randomization to the date of death.
Outcome measures
| Measure |
Exemestane
n=147 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=145 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 49.1 to
OS did not reach to the median during the study. Also, the number of deaths was not sufficient to determine the upper limit of 95% confidence interval for OS.
|
60.1 months
Interval 48.2 to
The number of deaths was not sufficient to determine the upper limit of 95% confidence interval for OS.
|
SECONDARY outcome
Timeframe: Up to 2008 days of the treatmentPopulation: Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.
TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.
Outcome measures
| Measure |
Exemestane
n=147 Participants
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=145 Participants
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
13.6 months
Interval 9.2 to 16.6
|
11.1 months
Interval 9.4 to 14.1
|
Adverse Events
Exemestane
Serious events: 19 serious events
Other events: 120 other events
Deaths: 0 deaths
Anastrozole
Serious events: 19 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane
n=149 participants at risk
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=149 participants at risk
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Prinzmetal angina
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
2/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
1.3%
2/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
3/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
2/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
2/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Spinal cord compression
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.67%
1/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Exemestane
n=149 participants at risk
One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
Anastrozole
n=149 participants at risk
One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.4%
5/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.7%
13/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
7/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.4%
14/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
12.8%
19/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.4%
14/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
6/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.7%
16/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
6.7%
10/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
6/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
6.0%
9/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
4.0%
6/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.1%
15/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
4.0%
6/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
36.2%
54/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
36.9%
55/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
5/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.4%
8/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.1%
18/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.4%
8/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
8.7%
13/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.7%
16/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
7/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
28/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
21.5%
32/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
17/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.8%
22/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
12.1%
18/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.4%
14/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
4/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.4%
8/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
7/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.1%
15/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
7.4%
11/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
7/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.1%
15/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
8.7%
13/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.1%
15/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.4%
8/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
5/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.7%
13/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.7%
4/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
9/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
9/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
9/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
22.1%
33/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.8%
22/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
6.0%
9/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
12/149 • Up to 2008 days of the treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER