Trial Outcomes & Findings for A Study of E7389 in Advanced/Metastatic Breast Cancer Patients (NCT NCT00097721)
NCT ID: NCT00097721
Last Updated: 2013-04-22
Results Overview
Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Confirmed 4 to 8 weeks after first observed
Results posted on
2013-04-22
Participant Flow
This study was recruited at 23 centers in U.S. during the period of Nov 2004 to Nov 2006.
Participant milestones
| Measure |
E7389 28 Day Schedule
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
71
|
33
|
Reasons for withdrawal
| Measure |
E7389 28 Day Schedule
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Progressive Disease
|
55
|
27
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Reason not given
|
1
|
1
|
Baseline Characteristics
A Study of E7389 in Advanced/Metastatic Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
E7389 28 Day Schedule
n=70 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=33 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.99 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=5 Participants
|
21 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Confirmed 4 to 8 weeks after first observedPopulation: Per Protocol Population (Independent Reviewer Assessment)
Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Outcome measures
| Measure |
E7389 28 Day Schedule
n=59 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=28 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response:
|
0 percentage of participants
|
0 percentage of participants
|
|
Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
10.2 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: From CR or partial response PR (whichever recorded first) to date of recurrent or progressive diseasePopulation: Intent to Treat/Safety Population (Investigator Assessment)
Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
E7389 28 Day Schedule
n=70 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=33 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Duration of Response
|
204 days
Interval 93.0 to 428.0
|
121 days
Interval 83.0 to 277.0
|
SECONDARY outcome
Timeframe: From start of study drug administration to progressive disease or deathPopulation: Per Protocol Population (Investigator Assessment)
Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.
Outcome measures
| Measure |
E7389 28 Day Schedule
n=59 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=28 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Progression Free Survival
|
57 days
Interval 1.0 to 413.0
|
86 days
Interval 1.0 to 453.0
|
SECONDARY outcome
Timeframe: From start of study drug administration to deathPopulation: Per Protocol Population (Investigator Assessment)
Defined as the time from the start of study drug administration until death from any cause
Outcome measures
| Measure |
E7389 28 Day Schedule
n=59 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=28 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Survival
|
239 days
Interval 15.0 to 826.0
|
NA days
Interval 18.0 to 620.0
This data point is not available due to insufficient number of deaths.
|
SECONDARY outcome
Timeframe: At Screening, Day 1 of each cycle, and 30 days after last dose of study drugThe FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.
Outcome measures
| Measure |
E7389 28 Day Schedule
n=40 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=21 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
Change From Baseline
|
-2.2 units on a scale
Interval -30.0 to 34.0
|
0 units on a scale
Interval -34.0 to 37.8
|
|
Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
Baseline Score
|
102.0 units on a scale
Interval 56.0 to 140.6
|
101.0 units on a scale
Interval 57.9 to 138.0
|
|
Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
Study Termination Score
|
104.3 units on a scale
Interval 50.0 to 143.0
|
98.4 units on a scale
Interval 65.0 to 139.0
|
Adverse Events
E7389 28 Day Schedule
Serious events: 23 serious events
Other events: 69 other events
Deaths: 0 deaths
E7389 21 Day Schedule
Serious events: 18 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389 28 Day Schedule
n=70 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=33 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.9%
2/70
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/70
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Inner Ear Disorder
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/70
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/70
|
3.0%
1/33
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.4%
1/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70
|
0.00%
0/33
|
|
General disorders
Asthenia
|
0.00%
0/70
|
3.0%
1/33
|
|
General disorders
Disease Progression
|
4.3%
3/70
|
3.0%
1/33
|
|
General disorders
Mucosal Inflammation
|
1.4%
1/70
|
0.00%
0/33
|
|
General disorders
Pain
|
0.00%
0/70
|
9.1%
3/33
|
|
General disorders
Pyrexia
|
4.3%
3/70
|
6.1%
2/33
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/70
|
3.0%
1/33
|
|
Infections and infestations
Bacterial Pyelonephritis
|
1.4%
1/70
|
3.0%
1/33
|
|
Infections and infestations
Bronchiectasis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Catheter Related Infection
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/70
|
3.0%
1/33
|
|
Infections and infestations
Meningitis Listeria
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Neutropenic Sepsis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Oropharyngeal Candidiasis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Sepsis
|
1.4%
1/70
|
0.00%
0/33
|
|
Infections and infestations
Upper Respiratory Tract
|
1.4%
1/70
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/70
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/70
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
5/70
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
1.4%
1/70
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.4%
1/70
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
1.4%
1/70
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.4%
1/70
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.4%
1/70
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
1.4%
1/70
|
0.00%
0/33
|
|
Psychiatric disorders
Confusional State
|
1.4%
1/70
|
0.00%
0/33
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/70
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary
|
0.00%
0/70
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/70
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.4%
1/70
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/70
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/70
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
1.4%
1/70
|
0.00%
0/33
|
|
Vascular disorders
Hypotension
|
1.4%
1/70
|
0.00%
0/33
|
Other adverse events
| Measure |
E7389 28 Day Schedule
n=70 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Schedule
n=33 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
48.6%
34/70
|
21.2%
7/33
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.7%
4/70
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.4%
22/70
|
18.2%
6/33
|
|
Blood and lymphatic system disorders
Neutropenia
|
77.1%
54/70
|
72.7%
24/33
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
8/70
|
3.0%
1/33
|
|
Cardiac disorders
Tachycardia
|
12.9%
9/70
|
3.0%
1/33
|
|
Eye disorders
Lacrimation Increased
|
5.7%
4/70
|
6.1%
2/33
|
|
Eye disorders
Vision Blurred
|
7.1%
5/70
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
8.6%
6/70
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal Distention
|
7.1%
5/70
|
9.1%
3/33
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.9%
9/70
|
15.2%
5/33
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.7%
4/70
|
3.0%
1/33
|
|
Gastrointestinal disorders
Constipation
|
35.7%
25/70
|
30.3%
10/33
|
|
Gastrointestinal disorders
Diarrhea
|
15.7%
11/70
|
24.2%
8/33
|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
5/70
|
12.1%
4/33
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
8/70
|
12.1%
4/33
|
|
Gastrointestinal disorders
Nausea
|
45.7%
32/70
|
42.4%
14/33
|
|
Gastrointestinal disorders
Oral Pain
|
5.7%
4/70
|
3.0%
1/33
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/70
|
6.1%
2/33
|
|
Gastrointestinal disorders
Stomatitis
|
18.6%
13/70
|
18.2%
6/33
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
13/70
|
24.2%
8/33
|
|
General disorders
Asthenia
|
4.3%
3/70
|
9.1%
3/33
|
|
General disorders
Chest Discomfort
|
7.1%
5/70
|
3.0%
1/33
|
|
General disorders
Chest Pain
|
4.3%
3/70
|
12.1%
4/33
|
|
General disorders
Chills
|
4.3%
3/70
|
9.1%
3/33
|
|
General disorders
Fatigue
|
58.6%
41/70
|
57.6%
19/33
|
|
General disorders
Mucosal Inflammation
|
7.1%
5/70
|
3.0%
1/33
|
|
General disorders
Edema
|
5.7%
4/70
|
3.0%
1/33
|
|
General disorders
Edema Peripheral
|
24.3%
17/70
|
15.2%
5/33
|
|
General disorders
Pain
|
11.4%
8/70
|
15.2%
5/33
|
|
General disorders
Pyrexia
|
32.9%
23/70
|
24.2%
8/33
|
|
Infections and infestations
Infection
|
1.4%
1/70
|
6.1%
2/33
|
|
Infections and infestations
Sinusitis
|
0.00%
0/70
|
6.1%
2/33
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.3%
3/70
|
21.2%
7/33
|
|
Infections and infestations
Urinary Tract Infection
|
12.9%
9/70
|
15.2%
5/33
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/70
|
9.1%
3/33
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
1.4%
1/70
|
9.1%
3/33
|
|
Investigations
Breath Sounds Abnormal
|
2.9%
2/70
|
6.1%
2/33
|
|
Investigations
White Blood Cell Count Decreased
|
1.4%
1/70
|
6.1%
2/33
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/70
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Anorexia
|
24.3%
17/70
|
18.2%
6/33
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.1%
5/70
|
12.1%
4/33
|
|
Metabolism and nutrition disorders
Dehydration
|
15.7%
11/70
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.7%
4/70
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.1%
12/70
|
21.2%
7/33
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.6%
6/70
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
1/70
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
9/70
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.9%
9/70
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.9%
9/70
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
8.6%
6/70
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
5/70
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
Pain Extemity
|
14.3%
10/70
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
5.7%
4/70
|
6.1%
2/33
|
|
Nervous system disorders
Coordination Abnormal
|
5.7%
4/70
|
0.00%
0/33
|
|
Nervous system disorders
Dizziness
|
14.3%
10/70
|
21.2%
7/33
|
|
Nervous system disorders
Dysgeusia
|
10.0%
7/70
|
9.1%
3/33
|
|
Nervous system disorders
Headache
|
17.1%
12/70
|
33.3%
11/33
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
2/70
|
9.1%
3/33
|
|
Nervous system disorders
Neuropathy
|
7.1%
5/70
|
6.1%
2/33
|
|
Nervous system disorders
Neuropathy Peripheral
|
20.0%
14/70
|
21.2%
7/33
|
|
Nervous system disorders
Paraesthesia
|
7.1%
5/70
|
6.1%
2/33
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.6%
6/70
|
3.0%
1/33
|
|
Nervous system disorders
Tremor
|
2.9%
2/70
|
6.1%
2/33
|
|
Psychiatric disorders
Insomnia
|
8.6%
6/70
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.9%
16/70
|
21.2%
7/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.1%
19/70
|
24.2%
8/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
7.1%
5/70
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
2/70
|
12.1%
4/33
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.4%
1/70
|
9.1%
3/33
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolarygeal Pain
|
8.6%
6/70
|
18.2%
6/33
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.7%
4/70
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/70
|
6.1%
2/33
|
|
Renal and urinary disorders
Dysuria
|
5.7%
4/70
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.3%
31/70
|
42.4%
14/33
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/70
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.3%
3/70
|
12.1%
4/33
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.4%
1/70
|
6.1%
2/33
|
|
Vascular disorders
Hot Flush
|
2.9%
2/70
|
9.1%
3/33
|
Additional Information
Eisai Call Center
Eisai Inc
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place