Trial Outcomes & Findings for Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer (NCT NCT00372996)
NCT ID: NCT00372996
Last Updated: 2015-10-28
Results Overview
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent \[%\] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
219 participants
Primary outcome timeframe
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
CP-751,871 Plus (+) Exemestane
Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Exemestane/CP-751,871 + Fulvestrant
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
|
Exemestane
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane/CP-751,871 + Exemestane
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
36
|
61
|
43
|
|
Overall Study
COMPLETED
|
42
|
22
|
33
|
23
|
|
Overall Study
NOT COMPLETED
|
37
|
14
|
28
|
20
|
Reasons for withdrawal
| Measure |
CP-751,871 Plus (+) Exemestane
Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Exemestane/CP-751,871 + Fulvestrant
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
|
Exemestane
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane/CP-751,871 + Exemestane
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
|
|---|---|---|---|---|
|
Overall Study
Death
|
11
|
4
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
6
|
9
|
5
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
0
|
4
|
0
|
|
Overall Study
Other
|
10
|
2
|
7
|
7
|
Baseline Characteristics
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
CP-751,871 + Exemestane
n=115 Participants
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
|
Exemestane
n=104 Participants
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 Years
STANDARD_DEVIATION 10.77 • n=99 Participants
|
62.7 Years
STANDARD_DEVIATION 10.86 • n=107 Participants
|
61.9 Years
STANDARD_DEVIATION 10.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 monthsPopulation: Full Analysis Set (FAS): all enrolled participants; grouped by randomized arm, where the first 10 participants enrolled but not randomly assigned to treatment were not included.
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent \[%\] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
Outcome measures
| Measure |
CP-751,871 + Exemestane
n=106 Participants
Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane
n=103 Participants
Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
11.0 months
Interval 8.1 to 12.9
|
9.2 months
Interval 7.0 to 13.0
|
PRIMARY outcome
Timeframe: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 monthsPopulation: FAS; only participants with baseline HbA1c \<5.7% were included in the analysis.
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.
Outcome measures
| Measure |
CP-751,871 + Exemestane
n=39 Participants
Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane
n=40 Participants
Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
|---|---|---|
|
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
|
13.2 months
Interval 8.1 to 19.5
|
9.9 months
Interval 7.0 to 13.6
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 monthsPopulation: FAS
Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.
Outcome measures
| Measure |
CP-751,871 + Exemestane
n=106 Participants
Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane
n=103 Participants
Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months
|
68.9 percentage of participants
Interval 59.1 to 77.5
|
64.1 percentage of participants
Interval 54.0 to 73.3
|
SECONDARY outcome
Timeframe: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871Population: The study was terminated early due to strategic reasons and pharmacokinetic (PK) sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871Population: The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871Population: The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusionPopulation: All randomized participants who started treatment and who had at least 1 sample submitted for the biomarker; collection of samples for this analysis was stopped after Amendment 6. All samples were negative to HAHA.
Negative human anti-human antibodies were defined as \<6.64
Outcome measures
| Measure |
CP-751,871 + Exemestane
n=66 samples
Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
Exemestane
Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
|---|---|---|
|
Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)
|
37 participants
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycle 1Population: The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapyPopulation: The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 monthsPopulation: The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 monthsPopulation: The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
Outcome data not reported
Adverse Events
CP-751,871 + Exemestane
Serious events: 38 serious events
Other events: 113 other events
Deaths: 0 deaths
CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
Exemestane
Serious events: 23 serious events
Other events: 96 other events
Deaths: 0 deaths
CP-751,871 + Exemestane (After Exemestane)
Serious events: 15 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-751,871 + Exemestane
n=115 participants at risk
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)
n=36 participants at risk
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
|
Exemestane
n=104 participants at risk
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Exemestane (After Exemestane)
n=43 participants at risk
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Embolism
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Macular fibrosis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
4.3%
5/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.0%
6/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Impaired healing
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pulmonary sepsis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Aphasia
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Grand mal convulsion
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sensory loss
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CP-751,871 + Exemestane
n=115 participants at risk
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)
n=36 participants at risk
Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
|
Exemestane
n=104 participants at risk
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
|
CP-751,871 + Exemestane (After Exemestane)
n=43 participants at risk
Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.7%
9/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.6%
5/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
5/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.2%
29/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
27.8%
10/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
39.4%
41/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
37.2%
16/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.1%
30/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.7%
6/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
17.3%
18/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
25.6%
11/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.6%
11/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
9.3%
4/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
5/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.6%
3/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
35.7%
41/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
33.3%
12/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.6%
8/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
9.6%
10/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.7%
18/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
13.9%
5/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.4%
15/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
20.9%
9/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.6%
11/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.7%
9/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
20.9%
9/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.8%
9/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
6.7%
7/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.6%
5/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.5%
19/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
19.4%
7/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
16/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.6%
8/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
11.3%
13/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
13.9%
5/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
24.0%
25/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
12.2%
14/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Deafness
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
2.6%
3/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
12/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.6%
11/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
9/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.8%
6/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
25.2%
29/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
22.2%
8/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.4%
16/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.2%
37/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
22.2%
8/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
21.2%
22/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
27.9%
12/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
13.0%
15/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.8%
5/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.6%
5/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
9/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.7%
9/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
3/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.5%
4/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
35/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
22.2%
8/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.3%
19/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
34.9%
15/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
8.7%
10/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
23/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.8%
6/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
14.8%
17/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
12.5%
13/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.6%
8/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
8/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
30.4%
35/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.6%
11/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
31.7%
33/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
37.2%
16/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
4.3%
5/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
9.6%
10/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
8/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.0%
6/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
9.6%
11/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.8%
5/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.8%
6/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.8%
5/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
13/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.7%
9/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
6.7%
7/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
18.3%
21/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
8/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.6%
8/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
9/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
13.0%
15/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
29.6%
34/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
27.8%
10/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.8%
5/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
32.6%
14/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
9.6%
11/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.8%
1/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.7%
41/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
36.1%
13/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
12.5%
13/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.2%
13/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
43.5%
50/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
25.0%
9/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
20.9%
9/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.5%
4/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Amnesia
|
2.6%
3/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
18.3%
21/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
12.5%
13/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.0%
6/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
18.3%
21/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
25.2%
29/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
19.4%
7/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
22.1%
23/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.2%
13/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.8%
5/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
11.3%
13/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.4%
15/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
27.9%
12/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
11.3%
13/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
14.4%
15/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.6%
5/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Breast pain
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
9.6%
10/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.6%
5/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.5%
4/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
5.2%
6/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
23/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
4/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
17/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.3%
7/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.5%
19/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
16.7%
6/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
13.5%
14/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.0%
15/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.3%
3/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
2/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.0%
8/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.9%
16/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
8/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.0%
15/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.7%
2/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
21.7%
25/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.6%
11/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.96%
1/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.9%
16/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.8%
6/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
9.3%
4/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
7/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
4/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.87%
1/115 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
2/36 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.9%
3/104 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43 • Adverse events (AEs) recorded from informed consent through and including 150 calendar days after the last administration of investigational product. Active reporting period for exemestane/fulvestrant clarified to 28 days after last dose in Amendment 6.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place