Trial Outcomes & Findings for Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery (NCT NCT00880542)
NCT ID: NCT00880542
Last Updated: 2020-08-10
Results Overview
After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Participants were followed for duration of study, an average of 1 year.
Results posted on
2020-08-10
Participant Flow
Dates of recruitment period: 08/20/2008 - 07/19/2010 Types of location: Academic medical clinics
There are no pre-assignment details to describe
Participant milestones
| Measure |
Sorafenib + Ifosfamide
|
|---|---|
|
Treatment Period (Sorafenib+Ifosfamide)
STARTED
|
7
|
|
Treatment Period (Sorafenib+Ifosfamide)
COMPLETED
|
4
|
|
Treatment Period (Sorafenib+Ifosfamide)
NOT COMPLETED
|
3
|
|
Response Evaluation Period(REP): PET/CT
STARTED
|
4
|
|
Response Evaluation Period(REP): PET/CT
COMPLETED
|
4
|
|
Response Evaluation Period(REP): PET/CT
NOT COMPLETED
|
0
|
|
REP: Surgical Resection
STARTED
|
4
|
|
REP: Surgical Resection
COMPLETED
|
3
|
|
REP: Surgical Resection
NOT COMPLETED
|
1
|
|
Post Surgical Evaluation
STARTED
|
3
|
|
Post Surgical Evaluation
COMPLETED
|
3
|
|
Post Surgical Evaluation
NOT COMPLETED
|
0
|
|
Continued Treatment Period
STARTED
|
0
|
|
Continued Treatment Period
COMPLETED
|
0
|
|
Continued Treatment Period
NOT COMPLETED
|
0
|
|
Follow-up Period
STARTED
|
7
|
|
Follow-up Period
COMPLETED
|
7
|
|
Follow-up Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Sorafenib + Ifosfamide
|
|---|---|
|
Treatment Period (Sorafenib+Ifosfamide)
Adverse Event
|
1
|
|
Treatment Period (Sorafenib+Ifosfamide)
disease progression
|
2
|
|
REP: Surgical Resection
progressive disease
|
1
|
Baseline Characteristics
Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Sorafenib + Ifosfamide
n=7 Participants
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for duration of study, an average of 1 year.Population: Due to the study closing early and the few number of participants enrolled, the outcome measures were not done.
After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: conclusion of studyPopulation: Due to study closing early and the few number of participants enrolled, the outcome measures were not done.
Outcome measures
Outcome data not reported
Adverse Events
Sorafenib + Ifosfamide
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib + Ifosfamide
n=7 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Grade 4 leukocytopenia related to Ifosfamide
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Grade 4 Neutopenia related to Ifosfamide
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Grade 3 and 4 Neutropenic fever related to Ifosfamide
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Grade 3 lower back pain due to disease or GCSF
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Grade 3 thrombocytopenia related to Ifosfamide
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Grade 3 lymphopenia related to Ifosfamide
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Metabolism and nutrition disorders
Grade 3 hypocalcemia related to possible vitamin D insufficiency
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
Grade 4 bowel perforation due to disease progression
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
Other adverse events
| Measure |
Sorafenib + Ifosfamide
n=7 participants at risk
|
|---|---|
|
General disorders
Epistaxis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Infections and infestations
Neutropenia fever
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Hepatobiliary disorders
Elevated international normalized ratio (INR)
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Cardiac disorders
Tachycardia
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Cardiac disorders
Chest pain
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
chills
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
shaking spells
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
weight loss
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
fever
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
anal fissure
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
bleeding with bowel movement
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
calluses, finger/toes
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
desquamation
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
ecchymosis below left eye
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
hand-foot syndrome
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Lt. heel plantar foot tenderness
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Painful blister on hand
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pionidal hidratitis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Purpura right arm
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash, hands/feet
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Skin and subcutaneous tissue disorders
redness areas under bunions
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
abdominal pain
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
abdominal bloating
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
constipation
|
71.4%
5/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
emesis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
hematemesis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
hemarrhoids
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
nausea
|
85.7%
6/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Gastrointestinal disorders
vomiting
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
asthenia
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
malnourished
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
pain-incision
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
pain-both feet
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
pain-post surgery
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
General disorders
throat sore
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Infections and infestations
mouth thrush
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Infections and infestations
positive VRE/Enterococolis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Metabolism and nutrition disorders
elevated triglyceride
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Metabolism and nutrition disorders
hypokalemia
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Metabolism and nutrition disorders
hyponatremia
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
right glenoid fossa fracture
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
bilateral lower extremities edema
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
dizziness
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
headache
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
pain/tingling left arm
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
somnolence
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Nervous system disorders
tingling in feet
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Psychiatric disorders
altered mental status
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Psychiatric disorders
confusion
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Psychiatric disorders
difficulty concentrating
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Psychiatric disorders
insomnia
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Renal and urinary disorders
dysuria
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Renal and urinary disorders
urine incontinence
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Renal and urinary disorders
urine pH less than 8
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
57.1%
4/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Vascular disorders
volume depletion
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Vascular disorders
deep vein thrombosis, right upper extremity
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
pedal edema
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
|
Blood and lymphatic system disorders
lower extremity edema
|
14.3%
1/7 • Adverse event(AE)data collected between 08/20/2008 and 7/19/2010, therefore AE reporting period is approximately 1 year and 11 months.
Systemic adverse event assessment with every physician contact day, either as outpatient or inpatient throughout the active treatment phase of the study and every three months in the follow-up period.
|
Additional Information
William Tap, MD
University of Calicornia Los Angeles (UCLA)
Phone: 888-798-0719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60