Trial Outcomes & Findings for Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer (NCT NCT02955394)
NCT ID: NCT02955394
Last Updated: 2025-07-09
Results Overview
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and \>= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
16 Weeks
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
Fulvestrant Without Enzalutamide
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
34
|
|
Overall Study
COMPLETED
|
25
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant Without Enzalutamide
n=27 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=34 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 13.08 • n=5 Participants
|
61.47 years
STANDARD_DEVIATION 10.10 • n=7 Participants
|
60.49 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
34 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksPopulation: 59 patients were evaluable. One patient was unable to participate in treatment after baseline and the other came off study for treatment change.
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and \>= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better.
Outcome measures
| Measure |
Fulvestrant Without Enzalutamide
n=26 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=33 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Number of Patients With a PEPI Score Equal to Zero at Post Treatment
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: 59 patients were evaluable. One patient was unable to participate in treatment after baseline and the other came off study for treatment change.
Disease-free survival is defined as the time in months from the start of fulvestrant until documented disease progression or death. Complete and partial response for the single drug arm and combination of enzalutamide/fulvestrant arm separately.
Outcome measures
| Measure |
Fulvestrant Without Enzalutamide
n=26 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=33 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Disease-free Survival
|
3.6 months
Interval 2.5 to 5.8
|
3.7 months
Interval 0.9 to 15.2
|
SECONDARY outcome
Timeframe: 4 yearsTo assess the association between PEPI score and the clinical, outcomes such as DFS, ORR, clinical benefit for all subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 WeeksPopulation: The number of evaluable patients for this outcome measure is 49 because these were the patients who had available lab data for AR%.
The strength of AR signaling was measured by the percentage of downstream AR-regulated genes that were expressed.
Outcome measures
| Measure |
Fulvestrant Without Enzalutamide
n=22 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=27 Participants
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Androgen Receptor (AR) Expression
|
85 percentage of genes expressed
Interval 10.0 to 100.0
|
80 percentage of genes expressed
Interval 10.0 to 100.0
|
Adverse Events
Fulvestrant Without Enzalutamide
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Fulvestrant With Enzalutamide
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fulvestrant Without Enzalutamide
n=27 participants at risk
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=34 participants at risk
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
Other adverse events
| Measure |
Fulvestrant Without Enzalutamide
n=27 participants at risk
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
Fulvestrant With Enzalutamide
n=34 participants at risk
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
1/27 • Number of events 2 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Hepatobiliary disorders
Alanine Aminotransferase Increased
|
3.7%
1/27 • Number of events 2 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Hepatobiliary disorders
Alkaline Phosphatase Increase
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
11.8%
4/34 • Number of events 4 • 51.78 months
|
|
Immune system disorders
Arthralgia
|
14.8%
4/27 • Number of events 4 • 51.78 months
|
14.7%
5/34 • Number of events 5 • 51.78 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Reproductive system and breast disorders
Breast pain
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
8.8%
3/34 • Number of events 3 • 51.78 months
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
8.8%
3/34 • Number of events 3 • 51.78 months
|
|
Nervous system disorders
Cognitive Disturbance
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Gastrointestinal disorders
Constipation
|
18.5%
5/27 • Number of events 5 • 51.78 months
|
11.8%
4/34 • Number of events 4 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 4 • 51.78 months
|
11.8%
4/34 • Number of events 4 • 51.78 months
|
|
Renal and urinary disorders
Creatinine increased
|
3.7%
1/27 • Number of events 2 • 51.78 months
|
11.8%
4/34 • Number of events 5 • 51.78 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 3 • 51.78 months
|
26.5%
9/34 • Number of events 11 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
General disorders
Fatigue
|
29.6%
8/27 • Number of events 10 • 51.78 months
|
50.0%
17/34 • Number of events 24 • 51.78 months
|
|
Gastrointestinal disorders
Abdominal Cramping
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
General disorders
Headache
|
11.1%
3/27 • Number of events 3 • 51.78 months
|
41.2%
14/34 • Number of events 21 • 51.78 months
|
|
Vascular disorders
Hot flashes
|
44.4%
12/27 • Number of events 12 • 51.78 months
|
38.2%
13/34 • Number of events 19 • 51.78 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Papular Rash
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
38.2%
13/34 • Number of events 14 • 51.78 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Investigations
Weight Gain
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
decreased activity
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
8.8%
3/34 • Number of events 3 • 51.78 months
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • Number of events 9 • 51.78 months
|
47.1%
16/34 • Number of events 18 • 51.78 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
General disorders
Pain
|
22.2%
6/27 • Number of events 8 • 51.78 months
|
38.2%
13/34 • Number of events 17 • 51.78 months
|
|
Nervous system disorders
Paresthesia
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Injury, poisoning and procedural complications
Seroma
|
3.7%
1/27 • Number of events 2 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Nervous system disorders
tremor
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Skin and subcutaneous tissue disorders
Skin disorders
|
18.5%
5/27 • Number of events 5 • 51.78 months
|
20.6%
7/34 • Number of events 7 • 51.78 months
|
|
Renal and urinary disorders
Urinary issues
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Reproductive system and breast disorders
vaginal dryness
|
3.7%
1/27 • Number of events 1 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • 51.78 months
|
5.9%
2/34 • Number of events 3 • 51.78 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/27 • 51.78 months
|
11.8%
4/34 • Number of events 10 • 51.78 months
|
|
Investigations
alanine transaminase increase
|
0.00%
0/27 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Eye disorders
Blurred Vision
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 3 • 51.78 months
|
|
Psychiatric disorders
agitation
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
Edema
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/27 • 51.78 months
|
8.8%
3/34 • Number of events 4 • 51.78 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • 51.78 months
|
14.7%
5/34 • Number of events 5 • 51.78 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • 51.78 months
|
17.6%
6/34 • Number of events 8 • 51.78 months
|
|
Eye disorders
Dry eye
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 2 • 51.78 months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 6 • 51.78 months
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Eye disorders
Eye disorders
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 3 • 51.78 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • 51.78 months
|
0.00%
0/34 • 51.78 months
|
|
Surgical and medical procedures
Hypertension
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Investigations
Loss of Taste
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Investigations
Muscle pain
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Investigations
Restless Leg Syndrome
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
Cold intolerance
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
Neck tightness
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
restless hands
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Renal and urinary disorders
Increase Urine Output
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
General disorders
Decreased ROM
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Psychiatric disorders
Decreased libido
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/27 • 51.78 months
|
11.8%
4/34 • Number of events 4 • 51.78 months
|
|
Metabolism and nutrition disorders
Pre-Diabeties
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Metabolism and nutrition disorders
Appetite Change
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Musculoskeletal and connective tissue disorders
Involuntary movement
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/27 • 51.78 months
|
8.8%
3/34 • Number of events 3 • 51.78 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/27 • 51.78 months
|
14.7%
5/34 • Number of events 6 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Nervous system disorders
Nervous System Disorders
|
0.00%
0/27 • 51.78 months
|
17.6%
6/34 • Number of events 8 • 51.78 months
|
|
Blood and lymphatic system disorders
Oral Hemorrhage
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Nervous system disorders
Peripheral Sensory neuropathy
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
0.00%
0/27 • 51.78 months
|
5.9%
2/34 • Number of events 2 • 51.78 months
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issues
|
0.00%
0/27 • 51.78 months
|
17.6%
6/34 • Number of events 7 • 51.78 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
General disorders
Toothache
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
|
Reproductive system and breast disorders
Vaginal Infection
|
0.00%
0/27 • 51.78 months
|
2.9%
1/34 • Number of events 1 • 51.78 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place