Trial Outcomes & Findings for Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer (NCT NCT01388647)
NCT ID: NCT01388647
Last Updated: 2015-08-28
Results Overview
Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start
Results posted on
2015-08-28
Participant Flow
This study was open to enrollment at four community oncology centers in the United States from July 2011 to June 2014.
Informed consent was obtained from all subjects. Subjects must have had no prior treatment for invasive breast cancer.
Participant milestones
| Measure |
Eribulin 1.1 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Eribulin 1.1 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Eribulin 1.1 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
Total
n=12 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Body Mass Index
|
32.4 kg/m^2
STANDARD_DEVIATION 6.79 • n=5 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 4.59 • n=7 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 5.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment startDefinitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).
Outcome measures
| Measure |
Eribulin 1.1 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Pathologic Response
Complete Response
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
|
Pathologic Response
Partial Response
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
SECONDARY outcome
Timeframe: Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (\> 50% reduction in longest diameter of pretreatment tumor), no response (\< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.
Outcome measures
| Measure |
Eribulin 1.1 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Clinical Response
Complete Response
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
|
Clinical Response
Partial Response
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
|
Clinical Response
Missing
|
0 percentage of participants
Interval 0.0 to 0.0
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 22 days from study treatment start, per subjectPopulation: The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.
The MTD is defined as the dose at which \<= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which \>= 2 of 6 subjects experience DLT.
Outcome measures
| Measure |
Eribulin 1.1 mg/m2
n=12 Participants
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb
|
1.1 mg/m^2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 22 days from study treatment start, per subjectDLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting \> 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.
Outcome measures
| Measure |
Eribulin 1.1 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 Participants
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Dose Limiting Toxicity (DLT)
Grade 4 thrombocytopenia
|
1 participants
|
1 participants
|
|
Dose Limiting Toxicity (DLT)
Inability to deliver all 3 agents at assigned dose
|
0 participants
|
2 participants
|
Adverse Events
Eribulin 1.1 mg/m2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Eribulin 1.4 mg/m2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin 1.1 mg/m2
n=6 participants at risk
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 participants at risk
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Neutrophil Count Decreased
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Surgical and medical procedures
Cholecystectomy
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Aortitis
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
Other adverse events
| Measure |
Eribulin 1.1 mg/m2
n=6 participants at risk
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
|
Eribulin 1.4 mg/m2
n=6 participants at risk
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
5/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Congenital, familial and genetic disorders
Hypophosphatasia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Eye disorders
Vision Blurred
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Abdominal Distension
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
100.0%
6/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Asthenia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Chest Pain
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Fatigue
|
83.3%
5/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Gait Disturbance
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Edema Peripheral
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Pain
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Immune system disorders
Hypersensitivity
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Infections and infestations
Skin Infection
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Neutrophil Count Decreased
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
83.3%
5/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Occult Blood Positive
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Platelet Count Decreased
|
83.3%
5/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Romberg Test Positive
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
Weight Decreased
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Investigations
White Blood Cell Count Decreased
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Metabolism and nutrition disorders
Hypouricemia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Dizziness
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Nervous system disorders
Syncope
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Reproductive system and breast disorders
Breast Discharge
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Reproductive system and breast disorders
Breast Pain
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
33.3%
2/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
66.7%
4/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Surgical and medical procedures
Antibiotic Prophylasis
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Deep Vein Thrombosis
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
|
Vascular disorders
Lymphedema
|
16.7%
1/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
0.00%
0/6 • Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60