Trial Outcomes & Findings for Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer (NCT NCT00810797)
NCT ID: NCT00810797
Last Updated: 2020-10-19
Results Overview
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Until disease progression of death from any cause, up to 3 years
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Treatment (Exemestane)
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Exemestane)
n=36 Participants
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Until disease progression of death from any cause, up to 3 yearsEstimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Exemestane)
n=36 Participants
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Progression-free Survival
|
4.3 months
Interval 2.0 to 6.5
|
SECONDARY outcome
Timeframe: Until disease progression or off treatment, assessed up to 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Exemestane)
n=36 Participants
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Overall Response Rate
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
Adverse Events
Treatment (Exemestane)
Serious events: 4 serious events
Other events: 35 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Treatment (Exemestane)
n=36 participants at risk
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Device related infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Exemestane)
n=36 participants at risk
Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
exemestane: Given orally
laboratory biomarker analysis: One year after completion of study treatment
quality-of-life assessment: One year after completion of study treatment
immunohistochemistry staining method: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
18/36 • Number of events 89 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
2.8%
1/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
5.6%
2/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial effusion
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Premature ventricular contractions
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
3/36 • Number of events 15 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye pain
|
2.8%
1/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
5.6%
2/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vitreous hemorrhage
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.9%
5/36 • Number of events 21 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
36.1%
13/36 • Number of events 28 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
30.6%
11/36 • Number of events 39 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
2/36 • Number of events 7 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
6/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
3/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
19.4%
7/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
12/36 • Number of events 55 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
13.9%
5/36 • Number of events 10 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
2/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • Number of events 7 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
13.9%
5/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
25.0%
9/36 • Number of events 37 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Facial pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
55.6%
20/36 • Number of events 107 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
16.7%
6/36 • Number of events 10 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Gait abnormal
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Ill-defined disorder
|
5.6%
2/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Irritability
|
13.9%
5/36 • Number of events 20 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
38.9%
14/36 • Number of events 52 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Gingival infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Opportunistic infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Otitis externa
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Peripheral nerve infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Phlebitis infective
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Tooth infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
13.9%
5/36 • Number of events 6 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Vaginal infection
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Oral cavity NOS
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
9/36 • Number of events 17 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
36.1%
13/36 • Number of events 70 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
58.3%
21/36 • Number of events 56 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
11.1%
4/36 • Number of events 18 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Coagulopathy
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatine phosphokinase increased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
13.9%
5/36 • Number of events 41 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Haptoglobin decreased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Laboratory test abnormal
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
30.6%
11/36 • Number of events 29 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
6/36 • Number of events 16 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
19.4%
7/36 • Number of events 18 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
25.0%
9/36 • Number of events 19 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
11.1%
4/36 • Number of events 15 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
8.3%
3/36 • Number of events 13 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
8/36 • Number of events 29 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.3%
3/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
61.1%
22/36 • Number of events 120 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
16.7%
6/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
16.7%
6/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
27.8%
10/36 • Number of events 24 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
19.4%
7/36 • Number of events 10 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
22.2%
8/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.6%
2/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
36.1%
13/36 • Number of events 26 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
13.9%
5/36 • Number of events 7 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
25.0%
9/36 • Number of events 15 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
9/36 • Number of events 36 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
9/36 • Number of events 51 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
2/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
44.4%
16/36 • Number of events 111 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
19.4%
7/36 • Number of events 28 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
13.9%
5/36 • Number of events 13 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.8%
10/36 • Number of events 34 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
3/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
9/36 • Number of events 43 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.3%
3/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
5.6%
2/36 • Number of events 6 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
11.1%
4/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
27.8%
10/36 • Number of events 36 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
13.9%
5/36 • Number of events 44 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.1%
4/36 • Number of events 12 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.4%
7/36 • Number of events 26 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
30.6%
11/36 • Number of events 36 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
8.3%
3/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
25.0%
9/36 • Number of events 27 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
30.6%
11/36 • Number of events 46 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Libido decreased
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urethral pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
4/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.6%
2/36 • Number of events 5 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
6/36 • Number of events 11 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
9/36 • Number of events 21 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
8.3%
3/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.9%
5/36 • Number of events 24 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
2/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.9%
5/36 • Number of events 11 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
2/36 • Number of events 30 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
16.7%
6/36 • Number of events 19 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
8.3%
3/36 • Number of events 4 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
2/36 • Number of events 3 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
13.9%
5/36 • Number of events 8 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hematoma
|
2.8%
1/36 • Number of events 1 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
66.7%
24/36 • Number of events 105 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
13.9%
5/36 • Number of events 16 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 2 • Adverse events were collected over a period of 5 years and 8 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place