Trial Outcomes & Findings for Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China (NCT NCT01176916)
NCT ID: NCT01176916
Last Updated: 2021-10-27
Results Overview
An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
564 participants
Primary outcome timeframe
2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
Results posted on
2021-10-27
Participant Flow
A total of 564 participants were assigned into the study and 558 participants received the study treatment. (6 participants were withdrawn from the study prior to the first dose of Aromasin.)
Participant milestones
| Measure |
Exemestane
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Overall Study
STARTED
|
564
|
|
Overall Study
Treated
|
558
|
|
Overall Study
Assigne But Not Treated
|
6
|
|
Overall Study
COMPLETED
|
397
|
|
Overall Study
NOT COMPLETED
|
167
|
Reasons for withdrawal
| Measure |
Exemestane
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
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|---|---|
|
Overall Study
Adverse Event
|
61
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Objective progression or relapse
|
17
|
|
Overall Study
Protocol Violation
|
24
|
|
Overall Study
Withdrawal by Subject
|
37
|
|
Overall Study
Other
|
6
|
|
Overall Study
Withdrawal prior to Treatment
|
6
|
Baseline Characteristics
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
Baseline characteristics by cohort
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
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|---|---|
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Age, Continuous
|
51.7 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
558 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
558 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The full analysis set (FAS) was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.
An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
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|---|---|
|
Time-to-Event
|
NA months
The median (95% confidence interval \[CI\]) time to event was not estimable because only a small number of participants experienced the event by the end of study.
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.
An event was defined as the following: 1) Loco-regional/distant recurrence of the primary breast cancer (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
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|---|---|
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Percentage of Participants Experiencing Each Event
Death due to any cause
|
0.7 percentage of participants
Interval 0.28 to 1.83
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|
Percentage of Participants Experiencing Each Event
Loco/distant recurrence of the primary BC
|
3.0 percentage of participants
Interval 1.91 to 4.82
|
|
Percentage of Participants Experiencing Each Event
Second primary/contralateral BC
|
0.4 percentage of participants
Interval 0.1 to 1.3
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.
Incidence rate (per annum) of the event was defined as a ratio of the number of events and the total exposure time (in years) to Aromasin therapy.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Incidence Rate of Each Event
Loco/distant recurrence of the primary BC
|
0.02995 events per person-year
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|
Incidence Rate of Each Event
Second primary/contralateral BC
|
0.00352 events per person-year
|
|
Incidence Rate of Each Event
Death due to any cause
|
0.00321 events per person-year
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.
A Cox proportional hazards regression model was used to evaluate the relationship between HER2 status level (binary) and time-to-event (Positive vs Negative). The method for selecting factors for the Cox regression model was based on significant results at univariate analysis and the clinical judgement for the multivariate model. Stepwise method was used for the selection of final independent variables. The criteria for stepwise selection were pentry = 0.25 and pstay = 0.15.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
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|---|---|
|
Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event
|
0.835 ratio
Interval 0.274 to 2.542
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The FAS was defined as all participants who received at least 1 dose of Aromasin during the observation period. All efficacy analyses were performed using the FAS.
A Cox proportional hazards regression model with stepwise selection was used to evaluate the influence of multiple disease variables on the time-to-event. The disease variables in the initial model included Eastern Cooperative Oncology Group \[ECOG\] performance status at diagnosis; and Tumor, Lymph Node and Metastasis \[TNM\] stage at initial diagnosis. The ECOG Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. ECOG performance status at diagnosis level included 0, 1, 2, 3 and 4, with Level 0 as the best status and Level 4 as the worst. The TNM system helps describe the size of cancer tumor and the extent to which it spreads to nearby tissues/distant parts of the body. TNM stage at initial diagnosis level included 1 (Stage I), 2 (Stage IIA), 3 (Stage IIB), 4 (Stage IIIA), 5 (Stage IIIB) and 6 (Stage IIIC), with Level 1 as the best status and Level 6 as the worst.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event
ECOG performance status at diagnosis
|
2.079 ratio
Interval 0.773 to 5.591
|
|
Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event
TNM stage at initial diagnosis
|
1.532 ratio
Interval 1.129 to 2.08
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The safety analysis set (SAS) was defined as all enrolled participants who took at least 1 dose of the study drug. All safety analyses were reported within the SAS.
Participants permanently discontinued from the study due to AEs were counted for this outcome measure. An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The number of participants with discontinuation due to all-causality and treatment-related AEs are reported below. Treatment-related AEs were determined by the investigator.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants With Discontinuation Due to Adverse Events (AEs)
treatment-related
|
47 Participants
|
|
Number of Participants With Discontinuation Due to Adverse Events (AEs)
all-causality
|
62 Participants
|
SECONDARY outcome
Timeframe: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)Population: The SAS was defined as all enrolled participants who took at least 1 dose of the study drug. All safety analyses were reported within the SAS.
All-causality TEAEs were counted for this outcome measure. TEAE is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. The number of participants with all-causality and treatment-related TEAEs are reported below. Treatment-related TEAEs were determined by the investigator.
Outcome measures
| Measure |
Exemestane
n=558 Participants
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
all-causality
|
345 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
treatment-related
|
222 Participants
|
Adverse Events
Exemestane
Serious events: 38 serious events
Other events: 82 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Exemestane
n=558 participants at risk
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Cardiac disorders
Angina unstable
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Endocrine disorders
Goitre
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Glaucoma
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.36%
2/558 • Number of events 2 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Chest pain
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Death
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Disease progression
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.36%
2/558 • Number of events 2 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
2/558 • Number of events 2 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Localised infection
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Lung infection
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Post procedural infection
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
2/558 • Number of events 2 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.36%
2/558 • Number of events 2 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.72%
4/558 • Number of events 4 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Renal cyst
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypertension
|
0.18%
1/558 • Number of events 1 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Exemestane
n=558 participants at risk
Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
50/558 • Number of events 51 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.9%
33/558 • Number of events 34 • 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
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