Trial Outcomes & Findings for Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer (NCT NCT00119262)
NCT ID: NCT00119262
Last Updated: 2014-05-15
Results Overview
Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry
Results posted on
2014-05-15
Participant Flow
E2104 was opened on October 6,2005, and closed on November 6, 2006 with the final accrual of 226 patients.Study participants included Eastern Cooperative Oncology Group (ECOG) entire group, North Central Cancer Treatment Group (NCCTG) entire group and Cancer and Leukemia Group B (CALGB) entire group.
Participant milestones
| Measure |
Arm A (ddBAC > BT > B)
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
122
|
|
Overall Study
Eligible
|
103
|
120
|
|
Overall Study
Treated
|
103
|
120
|
|
Overall Study
Eligible and Treated
|
102
|
119
|
|
Overall Study
COMPLETED
|
58
|
64
|
|
Overall Study
NOT COMPLETED
|
46
|
58
|
Reasons for withdrawal
| Measure |
Arm A (ddBAC > BT > B)
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
|
Overall Study
Adverse Event
|
33
|
35
|
|
Overall Study
other disease
|
0
|
2
|
|
Overall Study
ineligble
|
1
|
2
|
|
Overall Study
others
|
0
|
5
|
Baseline Characteristics
Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A (ddBAC > BT > B)
n=103 Participants
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=120 Participants
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
120 participants
n=7 Participants
|
223 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entryPopulation: 223 treated patients
Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.
Outcome measures
| Measure |
Arm A (ddBAC > BT > B)
n=103 Participants
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=120 Participants
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Congestive Heart Failure Rate
|
2.9 percentage of participants
Interval 0.6 to 8.3
|
2.5 percentage of participants
Interval 0.5 to 7.1
|
SECONDARY outcome
Timeframe: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatmentPopulation: Patients who were treated and had baseline and DIC5 LVEF values
The endpoint was measured by absolute decrease from baseline in LVEF of \>15% or \>10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.
Outcome measures
| Measure |
Arm A (ddBAC > BT > B)
n=94 Participants
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=113 Participants
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)
|
7.4 percentage of participants
Interval 3.0 to 14.7
|
3.5 percentage of participants
Interval 0.9 to 8.8
|
SECONDARY outcome
Timeframe: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatmentThe endpoint was measured by absolute decrease from baseline in LVEF of \>15% or \>10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.
Outcome measures
| Measure |
Arm A (ddBAC > BT > B)
n=72 Participants
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=86 Participants
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab
|
15.3 percentage of participants
Interval 7.9 to 25.7
|
11.6 percentage of participants
Interval 5.7 to 20.3
|
Adverse Events
Arm A (ddBAC > BT > B)
Serious events: 71 serious events
Other events: 103 other events
Deaths: 0 deaths
Arm B (ddAC > BT > B)
Serious events: 65 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (ddBAC > BT > B)
n=103 participants at risk
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=120 participants at risk
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Hepatobiliary disorders
AST increased
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr 0-2 neut, blood
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Hepatobiliary disorders
ALT increased
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Amylase increased
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Immune system disorders
Allergic reaction
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Blood and lymphatic system disorders
Anemia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
3.3%
4/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Leukopenia
|
21.4%
22/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
22.5%
27/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Neutropenia
|
27.2%
28/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
25.8%
31/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Thrombocytopenia
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Cardiac disorders
Cardiac-Ischemia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Vascular disorders
Hypertension
|
12.6%
13/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.8%
13/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
3.3%
4/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Fatigue
|
10.7%
11/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.8%
7/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Fever w/o neutropenia
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Weight gain
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Weight loss
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Vascular disorders
Hot flashes
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Anorexia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Dehydration
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), oral cavity
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
2.5%
3/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), pharynx
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
4.2%
5/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr3-4 neut,lung
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr3-4 neut, mucosa
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr3-4 neut, urinary tract
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr0-2 neut, bronchus
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr0-2 neut, catheter
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr 0-2 neut, lung
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr 0-2 neut, pharynx
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr 0-2 neut, skin
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/gr 0-2 neut, urinary tract
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/ unknown ANC, mucosa
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/ unknown ANC, oral activity/gums
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Infections and infestations
Infection w/ unknown ANC, upper airway NOS
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Nonneuropathic generalized weakness
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
CNS cerebrovascular Ischemia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Dizziness
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Neuropathy-sensory
|
7.8%
8/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
8.3%
10/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Syncope
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Hepatobiliary disorders
Gallbladder, pain
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Head/headache
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
6.7%
8/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Joint,pain
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
6.7%
8/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Muscle,pain
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
3.3%
4/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Neuropathic,pain
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.83%
1/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
4.2%
5/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
3.3%
4/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Injury, poisoning and procedural complications
Vascular assess, Thrombosis/Embolism
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
0.00%
0/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.97%
1/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Lymphopenia
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
Other adverse events
| Measure |
Arm A (ddBAC > BT > B)
n=103 participants at risk
Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
Arm B (ddAC > BT > B)
n=120 participants at risk
Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
11.7%
14/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Blood and lymphatic system disorders
Anemia
|
49.5%
51/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
50.0%
60/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Leukopenia
|
40.8%
42/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
34.2%
41/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Lymphopenia
|
4.9%
5/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.0%
12/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Neutropenia
|
27.2%
28/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
15.8%
19/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Thrombocytopenia
|
24.3%
25/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
26.7%
32/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Vascular disorders
Hypertension
|
43.7%
45/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
35.8%
43/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
18.4%
19/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
16.7%
20/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Fatigue
|
83.5%
86/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
85.0%
102/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Fever w/o neutropenia
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Psychiatric disorders
Insomnia
|
18.4%
19/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
20.0%
24/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Rigors/chills
|
7.8%
8/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
12.5%
15/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Sweating
|
7.8%
8/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
13.3%
16/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Weight gain
|
11.7%
12/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
11.7%
14/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Weight loss
|
31.1%
32/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
30.0%
36/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.0%
12/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
90.3%
93/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
75.8%
91/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Nail change
|
16.5%
17/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
23.3%
28/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
34.0%
35/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
25.8%
31/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
6.8%
7/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
11.7%
12/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Vascular disorders
Hot flashes
|
23.3%
24/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
35.8%
43/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
43/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
35.8%
43/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Constipation
|
35.0%
36/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
41.7%
50/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Dehydration
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
4.2%
5/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
35.9%
37/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
38.3%
46/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Dyspepsia
|
35.0%
36/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
35.8%
43/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), oral cavity
|
61.2%
63/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
51.7%
62/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), pharynx
|
14.6%
15/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.0%
12/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Nausea
|
85.4%
88/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
83.3%
100/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Taste disturbance
|
25.2%
26/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
30.8%
37/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Vomiting
|
36.9%
38/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
33.3%
40/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Oral activity, hemorrhage
|
6.8%
7/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Upper GI, hemorrhage NOS
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
2.5%
3/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
37.9%
39/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
29.2%
35/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Edema limb
|
4.9%
5/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.8%
13/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Alkaline phosphatase increased
|
35.0%
36/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
30.8%
37/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Hepatobiliary disorders
ALT increased
|
24.3%
25/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
19.2%
23/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Hepatobiliary disorders
AST increased
|
17.5%
18/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
27.5%
33/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Investigations
Bilirubin increased
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.6%
15/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.9%
3/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.9%
5/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
9.2%
11/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Renal and urinary disorders
Proteinuria
|
10.7%
11/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
19.2%
23/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Dizziness
|
8.7%
9/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
15.0%
18/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Psychiatric disorders
Anxiety
|
16.5%
17/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
4.2%
5/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Psychiatric disorders
Depression
|
8.7%
9/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
10.0%
12/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Neuropathy-motor
|
6.8%
7/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Neuropathy-sensory
|
69.9%
72/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
74.2%
89/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Eye disorders
Vision-blurred
|
1.9%
2/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
6.7%
8/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Eye disorders
Tearing
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
11.7%
14/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Eye disorders
Ocular-other
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Abonominal pain
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
8.3%
10/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.6%
14/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
16.7%
20/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thoracic pain NOS
|
7.8%
8/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
8.3%
10/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb,pain
|
3.9%
4/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Nervous system disorders
Head/headache
|
37.9%
39/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
42.5%
51/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Joint,pain
|
61.2%
63/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
62.5%
75/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Musculoskeletal and connective tissue disorders
Muscle,pain
|
55.3%
57/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
63.3%
76/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Gastrointestinal disorders
Pain NOS
|
5.8%
6/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
2.5%
3/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
General disorders
Pain-other
|
9.7%
10/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
7.5%
9/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
20/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
14.2%
17/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.2%
26/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
25.0%
30/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
12.6%
13/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
1.7%
2/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/103 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
5.0%
6/120 • assessed at the end of each cycle while on treatment and for 30 days after the end of treatment, and assessed every 3 months if patient is <2 years and every 6 months if patient is 2-3 years from study entry
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60