Trial Outcomes & Findings for Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer (NCT NCT00121134)
NCT ID: NCT00121134
Last Updated: 2013-12-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
1 year
Results posted on
2013-12-24
Participant Flow
This sequential cohort phase II study was performed in the outpatient setting at four institutions between 2005 and 2008.
A total of 164 participants were registered to enroll in the trial , but only 162 participants initiated treatment. So the evaluable population is 162 participants.
Participant milestones
| Measure |
Group A- Bevacizumab Alone
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
41
|
40
|
|
Overall Study
COMPLETED
|
24
|
26
|
20
|
31
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
21
|
9
|
Reasons for withdrawal
| Measure |
Group A- Bevacizumab Alone
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
|---|---|---|---|---|
|
Overall Study
Progression of Disease
|
5
|
3
|
4
|
2
|
|
Overall Study
Toxicity
|
4
|
7
|
13
|
5
|
|
Overall Study
Physician Decision
|
6
|
4
|
4
|
1
|
|
Overall Study
Treatment Delay
|
1
|
0
|
0
|
0
|
|
Overall Study
Intercurrent Illness
|
0
|
0
|
0
|
1
|
|
Overall Study
Patient Personal Reasons
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer
Baseline characteristics by cohort
| Measure |
Group A- Bevacizumab Alone
n=40 Participants
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
n=41 Participants
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
n=41 Participants
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
n=40 Participants
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.05 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
48.83 years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
48.71 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
49.55 years
STANDARD_DEVIATION 9.09 • n=4 Participants
|
49.03 years
STANDARD_DEVIATION 9.88 • n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
41 participants
n=5 Participants
|
40 participants
n=4 Participants
|
162 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Group A- Bevacizumab Alone
n=40 Participants
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
n=41 Participants
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
n=41 Participants
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
n=40 Participants
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
|---|---|---|---|---|
|
The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts
|
60 percentage of participants
|
58 percentage of participants
|
49 percentage of participants
|
76 percentage of participants
|
Adverse Events
Group A- Bevacizumab Alone
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Group C-Bevacizumab + Capcitabine(18 Wks)
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Group D-bevacizumab + Capecitibine (24wks)
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A- Bevacizumab Alone
n=40 participants at risk
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
n=41 participants at risk
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
n=41 participants at risk
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
n=40 participants at risk
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/40
|
0.00%
0/41
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/40
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.00%
0/40
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
0.00%
0/40
|
2.4%
1/41 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
|
Gastrointestinal disorders
Lower GI bleed
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/40
|
Other adverse events
| Measure |
Group A- Bevacizumab Alone
n=40 participants at risk
Bevacizumab 15 mg/kg every 3 wks for 1 year
|
Group B-Bevacizumab+Cyclophosphamide+Methotrexate
n=41 participants at risk
Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
|
Group C-Bevacizumab + Capcitabine(18 Wks)
n=41 participants at risk
capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
|
Group D-bevacizumab + Capecitibine (24wks)
n=40 participants at risk
capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
ALT, SGPT
|
7.5%
3/40 • Number of events 6
|
17.1%
7/41 • Number of events 8
|
4.9%
2/41 • Number of events 2
|
7.5%
3/40 • Number of events 7
|
|
Hepatobiliary disorders
AST, SGOT
|
20.0%
8/40 • Number of events 17
|
29.3%
12/41 • Number of events 42
|
17.1%
7/41 • Number of events 12
|
7.5%
3/40 • Number of events 9
|
|
Gastrointestinal disorders
Abdomen, pain
|
20.0%
8/40 • Number of events 10
|
4.9%
2/41 • Number of events 3
|
14.6%
6/41 • Number of events 15
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
7.5%
3/40 • Number of events 12
|
4.9%
2/41 • Number of events 10
|
4.9%
2/41 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.5%
5/40 • Number of events 17
|
0.00%
0/41
|
4.9%
2/41 • Number of events 2
|
7.5%
3/40 • Number of events 4
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40
|
2.4%
1/41 • Number of events 4
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 9
|
7.3%
3/41 • Number of events 6
|
5.0%
2/40 • Number of events 5
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
6/40 • Number of events 12
|
9.8%
4/41 • Number of events 12
|
19.5%
8/41 • Number of events 14
|
12.5%
5/40 • Number of events 15
|
|
Psychiatric disorders
Anxiety
|
25.0%
10/40 • Number of events 33
|
19.5%
8/41 • Number of events 20
|
19.5%
8/41 • Number of events 34
|
17.5%
7/40 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 7
|
0.00%
0/41
|
10.0%
4/40 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
back,pain
|
22.5%
9/40 • Number of events 16
|
26.8%
11/41 • Number of events 31
|
22.0%
9/41 • Number of events 34
|
15.0%
6/40 • Number of events 13
|
|
Metabolism and nutrition disorders
bicarbonate
|
0.00%
0/40
|
9.8%
4/41 • Number of events 11
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
bilirubin
|
5.0%
2/40 • Number of events 3
|
0.00%
0/41
|
4.9%
2/41 • Number of events 3
|
2.5%
1/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
bone, pain
|
7.5%
3/40 • Number of events 7
|
4.9%
2/41 • Number of events 3
|
7.3%
3/41 • Number of events 12
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
breast,pain
|
15.0%
6/40 • Number of events 12
|
7.3%
3/41 • Number of events 22
|
7.3%
3/41 • Number of events 14
|
2.5%
1/40 • Number of events 1
|
|
Blood and lymphatic system disorders
bruising
|
15.0%
6/40 • Number of events 12
|
7.3%
3/41 • Number of events 4
|
7.3%
3/41 • Number of events 11
|
2.5%
1/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
buttock, pain
|
0.00%
0/40
|
0.00%
0/41
|
0.00%
0/41
|
5.0%
2/40 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Chelitis
|
0.00%
0/40
|
0.00%
0/41
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
chest wall, pain
|
10.0%
4/40 • Number of events 13
|
4.9%
2/41 • Number of events 6
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest/thoracic pain NOS
|
2.5%
1/40 • Number of events 1
|
7.3%
3/41 • Number of events 5
|
4.9%
2/41 • Number of events 4
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
25.0%
10/40 • Number of events 25
|
12.2%
5/41 • Number of events 17
|
29.3%
12/41 • Number of events 31
|
32.5%
13/40 • Number of events 55
|
|
General disorders
Constitutional, other
|
5.0%
2/40 • Number of events 5
|
2.4%
1/41 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
10.0%
4/40 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
15/40 • Number of events 34
|
26.8%
11/41 • Number of events 27
|
26.8%
11/41 • Number of events 23
|
30.0%
12/40 • Number of events 22
|
|
Hepatobiliary disorders
creatinine
|
2.5%
1/40 • Number of events 4
|
12.2%
5/41 • Number of events 8
|
0.00%
0/41
|
20.0%
8/40 • Number of events 21
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 18
|
9.8%
4/41 • Number of events 15
|
7.3%
3/41 • Number of events 12
|
32.5%
13/40 • Number of events 28
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
30.0%
12/40 • Number of events 31
|
29.3%
12/41 • Number of events 30
|
48.8%
20/41 • Number of events 58
|
35.0%
14/40 • Number of events 32
|
|
Nervous system disorders
Dizziness
|
15.0%
6/40 • Number of events 7
|
12.2%
5/41 • Number of events 6
|
7.3%
3/41 • Number of events 6
|
12.5%
5/40 • Number of events 5
|
|
Eye disorders
Dry Eye Syndrome
|
0.00%
0/40
|
2.4%
1/41 • Number of events 8
|
4.9%
2/41 • Number of events 9
|
5.0%
2/40 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
5.0%
2/40 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.5%
3/40 • Number of events 5
|
0.00%
0/41
|
9.8%
4/41 • Number of events 10
|
5.0%
2/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
6/40 • Number of events 28
|
17.1%
7/41 • Number of events 26
|
19.5%
8/41 • Number of events 33
|
12.5%
5/40 • Number of events 11
|
|
Gastrointestinal disorders
Dyspepsia
|
22.5%
9/40 • Number of events 28
|
12.2%
5/41 • Number of events 16
|
7.3%
3/41 • Number of events 17
|
17.5%
7/40 • Number of events 30
|
|
Blood and lymphatic system disorders
Edema limb
|
12.5%
5/40 • Number of events 15
|
17.1%
7/41 • Number of events 29
|
12.2%
5/41 • Number of events 17
|
12.5%
5/40 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.5%
3/40 • Number of events 6
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
7.5%
3/40 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Extrapyramidal movement
|
5.0%
2/40 • Number of events 6
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
35.0%
14/40 • Number of events 43
|
22.0%
9/41 • Number of events 53
|
19.5%
8/41 • Number of events 34
|
15.0%
6/40 • Number of events 18
|
|
General disorders
fatigue
|
52.5%
21/40 • Number of events 117
|
70.7%
29/41 • Number of events 147
|
70.7%
29/41 • Number of events 149
|
72.5%
29/40 • Number of events 182
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
General disorders
fever w/o neutropenia
|
12.5%
5/40 • Number of events 6
|
17.1%
7/41 • Number of events 13
|
7.3%
3/41 • Number of events 3
|
10.0%
4/40 • Number of events 4
|
|
Gastrointestinal disorders
flatulence
|
5.0%
2/40 • Number of events 3
|
0.00%
0/41
|
0.00%
0/41
|
5.0%
2/40 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal-other
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
12.2%
5/41 • Number of events 7
|
7.5%
3/40 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
90.2%
37/41 • Number of events 170
|
95.0%
38/40 • Number of events 191
|
|
Nervous system disorders
Head/headache
|
77.5%
31/40 • Number of events 121
|
68.3%
28/41 • Number of events 99
|
56.1%
23/41 • Number of events 106
|
65.0%
26/40 • Number of events 113
|
|
Blood and lymphatic system disorders
hematologic-other
|
7.5%
3/40 • Number of events 13
|
22.0%
9/41 • Number of events 108
|
9.8%
4/41 • Number of events 14
|
25.0%
10/40 • Number of events 51
|
|
Blood and lymphatic system disorders
hemoglobin
|
2.5%
1/40 • Number of events 1
|
22.0%
9/41 • Number of events 58
|
7.3%
3/41 • Number of events 8
|
12.5%
5/40 • Number of events 12
|
|
Blood and lymphatic system disorders
hemorrhage-other
|
5.0%
2/40 • Number of events 7
|
4.9%
2/41 • Number of events 2
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
hemorrhoids
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
4.9%
2/41 • Number of events 4
|
0.00%
0/40
|
|
General disorders
Hot flashes
|
40.0%
16/40 • Number of events 89
|
24.4%
10/41 • Number of events 78
|
26.8%
11/41 • Number of events 58
|
45.0%
18/40 • Number of events 72
|
|
Metabolism and nutrition disorders
hypercalcemia
|
7.5%
3/40 • Number of events 13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
|
Endocrine disorders
Hyperglycemia
|
30.0%
12/40 • Number of events 28
|
22.0%
9/41 • Number of events 23
|
17.1%
7/41 • Number of events 12
|
25.0%
10/40 • Number of events 39
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
2/40 • Number of events 2
|
4.9%
2/41 • Number of events 5
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.5%
1/40 • Number of events 1
|
9.8%
4/41 • Number of events 9
|
9.8%
4/41 • Number of events 5
|
5.0%
2/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.5%
1/40 • Number of events 7
|
2.4%
1/41 • Number of events 4
|
9.8%
4/41 • Number of events 24
|
5.0%
2/40 • Number of events 6
|
|
Blood and lymphatic system disorders
Hypertension
|
55.0%
22/40 • Number of events 50
|
39.0%
16/41 • Number of events 66
|
34.1%
14/41 • Number of events 54
|
35.0%
14/40 • Number of events 44
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
4/40 • Number of events 17
|
0.00%
0/41
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.5%
7/40 • Number of events 14
|
9.8%
4/41 • Number of events 5
|
2.4%
1/41 • Number of events 1
|
12.5%
5/40 • Number of events 6
|
|
Endocrine disorders
Hypoglycemia
|
7.5%
3/40 • Number of events 3
|
9.8%
4/41 • Number of events 6
|
4.9%
2/41 • Number of events 2
|
7.5%
3/40 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
6/40 • Number of events 14
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
5.0%
2/40 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.5%
3/40 • Number of events 11
|
14.6%
6/41 • Number of events 10
|
0.00%
0/41
|
5.0%
2/40 • Number of events 10
|
|
Infections and infestations
Infection Gr0-2 neut, bronchus
|
7.5%
3/40 • Number of events 4
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
10.0%
4/40 • Number of events 7
|
7.3%
3/41 • Number of events 3
|
12.2%
5/41 • Number of events 10
|
7.5%
3/40 • Number of events 4
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 3
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
12.5%
5/40 • Number of events 5
|
7.3%
3/41 • Number of events 4
|
14.6%
6/41 • Number of events 11
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
5.0%
2/40 • Number of events 3
|
2.4%
1/41 • Number of events 2
|
4.9%
2/41 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Infection w/unk ANC upper airway NOS
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/41
|
5.0%
2/40 • Number of events 3
|
|
Infections and infestations
Infection-other
|
20.0%
8/40 • Number of events 9
|
9.8%
4/41 • Number of events 4
|
2.4%
1/41 • Number of events 2
|
10.0%
4/40 • Number of events 6
|
|
General disorders
Insomnia
|
20.0%
8/40 • Number of events 48
|
14.6%
6/41 • Number of events 19
|
22.0%
9/41 • Number of events 45
|
25.0%
10/40 • Number of events 44
|
|
Reproductive system and breast disorders
irregular menses
|
5.0%
2/40 • Number of events 8
|
0.00%
0/41
|
2.4%
1/41 • Number of events 5
|
5.0%
2/40 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
joint, pain
|
77.5%
31/40 • Number of events 156
|
43.9%
18/41 • Number of events 110
|
56.1%
23/41 • Number of events 111
|
60.0%
24/40 • Number of events 103
|
|
Musculoskeletal and connective tissue disorders
joint-function
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytes
|
22.5%
9/40 • Number of events 23
|
26.8%
11/41 • Number of events 34
|
9.8%
4/41 • Number of events 6
|
17.5%
7/40 • Number of events 19
|
|
Nervous system disorders
Memory impairment
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 3
|
0.00%
0/41
|
5.0%
2/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Metabolic/laboratory-other
|
30.0%
12/40 • Number of events 42
|
29.3%
12/41 • Number of events 67
|
9.8%
4/41 • Number of events 7
|
12.5%
5/40 • Number of events 11
|
|
Infections and infestations
Muco/stomatitis(symptom) oral cavity
|
22.5%
9/40 • Number of events 29
|
24.4%
10/41 • Number of events 43
|
48.8%
20/41 • Number of events 56
|
35.0%
14/40 • Number of events 36
|
|
Infections and infestations
Muco/stomatitis by exam, oral cavity
|
2.5%
1/40 • Number of events 1
|
12.2%
5/41 • Number of events 22
|
19.5%
8/41 • Number of events 13
|
17.5%
7/40 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
25.0%
10/40 • Number of events 28
|
9.8%
4/41 • Number of events 11
|
14.6%
6/41 • Number of events 13
|
10.0%
4/40 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
7.5%
3/40 • Number of events 3
|
17.1%
7/41 • Number of events 29
|
14.6%
6/41 • Number of events 16
|
12.5%
5/40 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/40
|
7.3%
3/41 • Number of events 12
|
2.4%
1/41 • Number of events 2
|
5.0%
2/40 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
0.00%
0/40
|
4.9%
2/41 • Number of events 2
|
4.9%
2/41 • Number of events 3
|
12.5%
5/40 • Number of events 23
|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • Number of events 23
|
46.3%
19/41 • Number of events 37
|
31.7%
13/41 • Number of events 27
|
42.5%
17/40 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
Neck,pain
|
20.0%
8/40 • Number of events 14
|
2.4%
1/41 • Number of events 1
|
7.3%
3/41 • Number of events 4
|
10.0%
4/40 • Number of events 8
|
|
Nervous system disorders
Neuropathy-sensory
|
25.0%
10/40 • Number of events 48
|
26.8%
11/41 • Number of events 47
|
26.8%
11/41 • Number of events 45
|
37.5%
15/40 • Number of events 58
|
|
Blood and lymphatic system disorders
Neutrophils
|
15.0%
6/40 • Number of events 12
|
31.7%
13/41 • Number of events 26
|
9.8%
4/41 • Number of events 4
|
17.5%
7/40 • Number of events 17
|
|
General disorders
Nonneuropathic generalized weakness
|
5.0%
2/40 • Number of events 11
|
0.00%
0/41
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Blood and lymphatic system disorders
Nose, hemorrhage
|
40.0%
16/40 • Number of events 45
|
46.3%
19/41 • Number of events 54
|
29.3%
12/41 • Number of events 28
|
35.0%
14/40 • Number of events 40
|
|
Blood and lymphatic system disorders
Oral cavity, hemorrhage
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 2
|
2.4%
1/41 • Number of events 3
|
7.5%
3/40 • Number of events 4
|
|
General disorders
Oral gums, pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/41
|
5.0%
2/40 • Number of events 3
|
|
Nervous system disorders
Pain NOS
|
5.0%
2/40 • Number of events 9
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/40
|
|
Nervous system disorders
Pain-other
|
15.0%
6/40 • Number of events 15
|
22.0%
9/41 • Number of events 16
|
14.6%
6/41 • Number of events 12
|
17.5%
7/40 • Number of events 10
|
|
Cardiac disorders
Palpitations
|
5.0%
2/40 • Number of events 5
|
4.9%
2/41 • Number of events 7
|
0.00%
0/41
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Platelets
|
5.0%
2/40 • Number of events 9
|
9.8%
4/41 • Number of events 14
|
9.8%
4/41 • Number of events 8
|
12.5%
5/40 • Number of events 22
|
|
Renal and urinary disorders
Proteinuria
|
52.5%
21/40 • Number of events 61
|
68.3%
28/41 • Number of events 89
|
61.0%
25/41 • Number of events 77
|
52.5%
21/40 • Number of events 71
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.0%
6/40 • Number of events 8
|
4.9%
2/41 • Number of events 3
|
4.9%
2/41 • Number of events 5
|
12.5%
5/40 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory-other
|
17.5%
7/40 • Number of events 11
|
29.3%
12/41 • Number of events 43
|
24.4%
10/41 • Number of events 26
|
40.0%
16/40 • Number of events 44
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
17.5%
7/40 • Number of events 12
|
19.5%
8/41 • Number of events 12
|
12.2%
5/41 • Number of events 9
|
7.5%
3/40 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
4.9%
2/41 • Number of events 5
|
20.0%
8/40 • Number of events 12
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
10.0%
4/40 • Number of events 9
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Rigors/chills
|
5.0%
2/40 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
4.9%
2/41 • Number of events 3
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
10.0%
4/40 • Number of events 5
|
4.9%
2/41 • Number of events 2
|
14.6%
6/41 • Number of events 12
|
17.5%
7/40 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.5%
3/40 • Number of events 4
|
9.8%
4/41 • Number of events 12
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Taste disturbance
|
17.5%
7/40 • Number of events 27
|
9.8%
4/41 • Number of events 15
|
17.1%
7/41 • Number of events 36
|
20.0%
8/40 • Number of events 29
|
|
Eye disorders
Tearing
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/41
|
5.0%
2/40 • Number of events 3
|
|
General disorders
Throat/Pharynx/larynx,pain
|
5.0%
2/40 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Reproductive system and breast disorders
Vagina, hemorrhage
|
0.00%
0/40
|
2.4%
1/41 • Number of events 2
|
0.00%
0/41
|
5.0%
2/40 • Number of events 4
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
5.0%
2/40 • Number of events 3
|
4.9%
2/41 • Number of events 3
|
2.4%
1/41 • Number of events 2
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Vaginal dryness
|
15.0%
6/40 • Number of events 19
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Eye disorders
Vision-blurred
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 3
|
7.3%
3/41 • Number of events 5
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Voice changes/dysarthria
|
10.0%
4/40 • Number of events 14
|
12.2%
5/41 • Number of events 36
|
7.3%
3/41 • Number of events 8
|
5.0%
2/40 • Number of events 13
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40 • Number of events 12
|
7.3%
3/41 • Number of events 6
|
14.6%
6/41 • Number of events 7
|
22.5%
9/40 • Number of events 13
|
|
General disorders
Weight Gain
|
2.5%
1/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/41
|
7.5%
3/40 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Wound-non-infectious
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Cardiac disorders
Cardiac-other
|
2.5%
1/40 • Number of events 3
|
7.3%
3/41 • Number of events 7
|
7.3%
3/41 • Number of events 4
|
5.0%
2/40 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place