Trial Outcomes & Findings for Bevacizumab and Radiation Therapy for Sarcomas (NCT NCT00356031)
NCT ID: NCT00356031
Last Updated: 2017-05-19
Results Overview
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
3 years
Results posted on
2017-05-19
Participant Flow
Subjects were recruited from the multidisciplinary sarcoma clinic, surgical oncology, radiation oncology, and medical oncology clinics at the Massachusetts General Hospital, Brigham and Women's Hospital, or Dana-Farber Cancer Institute.
Participant milestones
| Measure |
Experimental: Bevacizumab, Radiation, and Surgery
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab and Radiation Therapy for Sarcomas
Baseline characteristics by cohort
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
|
Sarcoma Histology
Fibroblastic
|
8 Participants
n=99 Participants
|
|
Sarcoma Histology
Liposarcoma
|
6 Participants
n=99 Participants
|
|
Sarcoma Histology
Leiomyosarcoma
|
4 Participants
n=99 Participants
|
|
Sarcoma Histology
Fibroblastic Osteosarcoma
|
1 Participants
n=99 Participants
|
|
Sarcoma Histology
Not Otherwise Specified
|
1 Participants
n=99 Participants
|
|
Sarcoma Grade
Low
|
2 Participants
n=99 Participants
|
|
Sarcoma Grade
Intermediate
|
8 Participants
n=99 Participants
|
|
Sarcoma Grade
High
|
10 Participants
n=99 Participants
|
|
Median Sarcoma Size
|
8.25 Centimeters (cm)
n=99 Participants
|
|
Sarcoma Location
Extremity
|
13 Participants
n=99 Participants
|
|
Sarcoma Location
Trunk
|
1 Participants
n=99 Participants
|
|
Sarcoma Location
retroperitoneal/pelvis tumors
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsThe count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
80-89% necrosis
|
2 participants
|
|
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
90-99% necrosis
|
4 participants
|
|
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
100% necrosis
|
3 participants
|
SECONDARY outcome
Timeframe: baseline and 3 yearsThe percentage change in median microvessel density (MVD) after Bevacizumab treatment alone
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Change in Median Microvessel Density (MVD) After Bevacizumab Alone
|
53 percentage of change in MVD
Interval 28.6 to 77.4
|
SECONDARY outcome
Timeframe: 3 yearsThe percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Average Change in Blood Flow, Blood Volume,and Permeability Surface Area
|
67 Percent Reduction
Interval 62.0 to 72.0
|
SECONDARY outcome
Timeframe: 3 yearsThe number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Local Control Rate
Local Recurrence
|
1 Participants
|
|
Local Control Rate
No Local Recurrence
|
19 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Distant Recurrence
Distant recurrence
|
7 Participants
|
|
Distant Recurrence
No distant recurrence
|
13 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.
Outcome measures
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 Participants
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Disease Free Survival
|
7 Months
Interval 2.0 to 36.0
|
Adverse Events
Bevacizumab, Radiation, and Surgery
Serious events: 3 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 participants at risk
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Reproductive system and breast disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
Other adverse events
| Measure |
Bevacizumab, Radiation, and Surgery
n=20 participants at risk
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
15.0%
3/20 • Number of events 12 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Immune system disorders
Allergic rhinitis
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
10/20 • Number of events 23 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Leukocytes
|
15.0%
3/20 • Number of events 15 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
35.0%
7/20 • Number of events 21 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Neutrophils
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Platelets
|
10.0%
2/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Cardiac disorders
Hypertension
|
50.0%
10/20 • Number of events 49 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Fatigue
|
55.0%
11/20 • Number of events 40 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Fever w/o neutropenia
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Insomnia
|
20.0%
4/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Partial thromboplastin time
|
15.0%
3/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.0%
3/20 • Number of events 9 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
15.0%
3/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Wound - non-infectious
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
25.0%
5/20 • Number of events 17 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
3/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
30.0%
6/20 • Number of events 10 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
5.0%
1/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Number of events 12 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Taste disturbance
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
GI-other
|
10.0%
2/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Hematoma
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Nose, hemorrhage
|
15.0%
3/20 • Number of events 6 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Hemorrhage-other
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection Gr0-2 neut, stomach
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection Gr0-2 neut, vagina
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Infections and infestations
Infection w/ unk ANC urinary tract NOS
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Blood and lymphatic system disorders
Edema limb
|
10.0%
2/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.0%
4/20 • Number of events 18 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
10.0%
2/20 • Number of events 8 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
15.0%
3/20 • Number of events 8 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.0%
1/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
3/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
65.0%
13/20 • Number of events 28 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.0%
6/20 • Number of events 10 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Proteinuria
|
20.0%
4/20 • Number of events 12 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-other
|
5.0%
1/20 • Number of events 12 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis, extremity lower
|
5.0%
1/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
15.0%
3/20 • Number of events 8 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Nervous system disorders
Anxiety
|
5.0%
1/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Nervous system disorders
Depression
|
15.0%
3/20 • Number of events 5 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Nervous system disorders
Neuropathy-sensory
|
10.0%
2/20 • Number of events 11 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Nervous system disorders
Neurologic-other
|
5.0%
1/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Abdomen, pain
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
15.0%
3/20 • Number of events 7 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thoracic pain NOS
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
15.0%
3/20 • Number of events 8 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Head/headache
|
15.0%
3/20 • Number of events 7 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
15.0%
3/20 • Number of events 8 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Musculoskeletal and connective tissue disorders
Pelvic, pain
|
5.0%
1/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Gastrointestinal disorders
Throat/pharynx/larynx, pain
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.0%
2/20 • Number of events 2 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
General disorders
Pain-other
|
15.0%
3/20 • Number of events 3 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
10.0%
2/20 • Number of events 6 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Reproductive system and breast disorders
Irregular menses
|
10.0%
2/20 • Number of events 4 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor lysis syndrome
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Vascular disorders
Phlebitis
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
|
Vascular disorders
Visceral arterial ischemia
|
5.0%
1/20 • Number of events 1 • 3 years
Laboratory tests and physical exams were performed as a part of routine study visits.
|
Additional Information
Dr. Sam S. Yoon, Principal Investigator
Massachusetts General Hospital
Phone: 617 643-9475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place