Trial Outcomes & Findings for Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer (NCT NCT00903006)
NCT ID: NCT00903006
Last Updated: 2015-02-02
Results Overview
Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels: Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle. MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1) Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
28 day cycle
Results posted on
2015-02-02
Participant Flow
Recruitment Period: November 19, 2009 to February 13, 2012. All recruitment done in medical clinical at the University of Texas (UT) MD Anderson Cancer Center.
Out of 11 participants registered to the trial, five (5) were screen failures and thus excluded from the trial. The Phase I portion of study began with the first three arms: 1) Fulvestrant, 2) Fulvestrant + Low Dose Dasatinib and 3) Fulvestrant + Low Dose of MK-0646.
Participant milestones
| Measure |
Group 1: Fulvestrant
Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
|
Group 2: Fulvestrant + Dasatinib
Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Group 3: Fulvestrant + MK-0646
Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
|
Group 4: Fulvestrant, MK-0646 + Dasatinib
Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Fulvestrant
Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
|
Group 2: Fulvestrant + Dasatinib
Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Group 3: Fulvestrant + MK-0646
Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
|
Group 4: Fulvestrant, MK-0646 + Dasatinib
Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
3
|
1
|
0
|
Baseline Characteristics
Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1: Fulvestrant
n=2 Participants
Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
|
Group 2: Fulvestrant + Dasatinib
n=3 Participants
Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Group 3: Fulvestrant + MK-0646
n=1 Participants
Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
|
Group 4: Fulvestrant, MK-0646 + Dasatinib
Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
5 participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
63 years
n=7 Participants
|
36 years
n=5 Participants
|
—
|
57.5 years
n=21 Participants
|
|
Gender
Female
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
6 participants
n=21 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
4 participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
5 participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 day cyclePopulation: Study terminated early; Analysis not available due to smaller sample size.
Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels: Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle. MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1) Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, after two 28 day cycles, until disease progression.Outcome measures
Outcome data not reported
Adverse Events
Group 1: Fulvestrant
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: Fulvestrant + Dasatinib
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: Fulvestrant + MK-0646
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 4: Fulvestrant, MK-0646 + Dasatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Fulvestrant
n=2 participants at risk
Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
|
Group 2: Fulvestrant + Dasatinib
n=3 participants at risk
Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Group 3: Fulvestrant + MK-0646
n=1 participants at risk
Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
|
Group 4: Fulvestrant, MK-0646 + Dasatinib
Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Gait abnormal
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
Other adverse events
| Measure |
Group 1: Fulvestrant
n=2 participants at risk
Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
|
Group 2: Fulvestrant + Dasatinib
n=3 participants at risk
Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
Group 3: Fulvestrant + MK-0646
n=1 participants at risk
Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
|
Group 4: Fulvestrant, MK-0646 + Dasatinib
Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
100.0%
2/2 • Number of events 5 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 8 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Blood and lymphatic system disorders
Abnormal Blood Tests
|
100.0%
2/2 • Number of events 4 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
3/3 • Number of events 12 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain, Generalized
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Blood and lymphatic system disorders
Lymphocyte absolute count decreased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
General disorders
Burning Sensation in throat
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 4 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Skin and subcutaneous tissue disorders
Rash/Keratosis
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
3/3 • Number of events 4 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Investigations
Fever
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Gait abnormal
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Endocrine disorders
Growth hormone abnormal
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
3/3 • Number of events 4 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Endocrine disorders
Hot flashes
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
General disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Metabolic disorders
|
100.0%
2/2 • Number of events 12 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
3/3 • Number of events 20 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 9 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Nervous system disorders
Paresthesia of the hand
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Nervous system disorders
Somnolence
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Nervous system disorders
Neuropathy, Leg
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Eye disorders
Red irritated eyes
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
100.0%
2/2 • Number of events 8 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 6 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Pressure Chest
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
66.7%
2/3 • Number of events 4 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Eye disorders
Retinopathy
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum glucose decrease
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
General disorders
Sweating
|
50.0%
1/2 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 5 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
General disorders
Weight loss
|
0.00%
0/2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
33.3%
1/3 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping
|
50.0%
1/2 • Number of events 1 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
0.00%
0/3 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
100.0%
1/1 • Number of events 2 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
—
0/0 • Adverse event evaluation through each 28 day cycle and 3-4 weeks after the last cycle. Overall study collection period May 2010 to January 2012.
|
Additional Information
Ana Gonzalez-Angulo, MD / Associate Professor, Breast Medical Oncology
University of Texas MD Anderson Cancer Center
Phone: 713-792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place