XAGastric: Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00447330
• Collaborator: Hoffmann-La Roche (Industry), Sanofi (Industry), Genentech, Inc. (Industry)
• Enrollment: 60
• Locations: 2
• Arm: 1
• Duration (Months): 88.9
• Patients Per Site: 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the progression free survival of capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic esophagogastric adenocarcinomas.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms; Stomach Neoplasms; Neoplasm Metastasis	Drug: capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin)	Phase 2

Detailed Description

The number of new cases of esophageal and gastric cancers in the United States in 2005 is 14520 for esophageal cancer and 21860 for gastric cancer. Unfortunately, esophageal and gastric cancers will also account for 13570 and 11550 deaths, respectively, in 2005. The 5 year survival rates for metastatic gastroesophageal, GE junctional, and gastric cancers are less than 5%. The major current treatment modality for patients with advanced esophageal, GE junctional, and gastric adenocarcinomas is systemic chemotherapy.

We seek to investigate the efficacy of capecitabine and oxaliplatin in combination with bevacizumab as first line treatment for metastatic esophagogastric cancers. The choice of capecitabine and oxaliplatin is made to develop a user-friendly biologically-based regimen, offering patients oral capecitabine in place of continuous 5FU infusion pumps. Since capecitabine can be given crushed this regimen may both be active and user-friendly. Preliminary data in colorectal cancer suggest that the regimen of capecitabine, oxaliplatin, and bevacizumab has comparable activity to FOLFOX-bevacizumab. The goal of the proposed regimen is to define a capecitabine and oxaliplatin-based regimen that optimizes biological approaches over cytotoxic approaches. The addition of bevacizumab to chemotherapy regimens for metastatic colorectal cancer, metastatic non-small cell lung cancer, and metastatic breast cancer has shown to improve response rates and overall survival. If active, this regimen could serve as a first line comparator to the capecitabine, oxaliplatin, and epirubicin combination. This approach will also help to simplify regimen development across gastrointestinal cancers.

In addition to the primary efficacy endpoint of this protocol, several correlative endpoints will also be examined in an exploratory manner. The importance of developing blood-based and tumor biomarkers has been extensively reviewed. However, the role of such predictive markers has not been well studied for XELOX-A. This information is important since it may help define which populations are most likely to benefit and most likely to suffer significant toxicity from this important GI cancer regimen. This biomarker approach may also help understand and define mechanisms of sensitivity, resistance, and toxicity that may be used to guide future hypothesis-driven studies designed to improve the efficacy and safety of this regimen. The correlative biomarker endpoints include serum, plasma and urine biomarkers (e.g. VEGF and bFGF), a wound healing model of angiogenesis, and tumor biopsy studies .

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase ll Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1

Drug: capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin); Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.

Outcome Measures

Primary Outcome Measures

1. Median Progression-Free Survival (PFS) [5 years from study start date]

   Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.

Secondary Outcome Measures

1. To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma [Every 21 days]

   Number of subjects who experienced an adverse event

2. Response Rate [Every 9 weeks for up to 1 year]

   The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.

3. Median Survival [5 years after study start date]

   Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Primary Inclusion Criteria:

• Histologically or cytologically documented and radiographically measurable adenocarcinoma of the esophagus or stomach that is metastatic/recurrent and not amenable to potentially curative treatment

• No prior therapy for metastatic disease

• Prior radiation therapy is permitted, provided it is completed > 28 days prior to day 1 of study drug

• Normal organ and marrow function

• Karnofsky Performance Status 70-100%

Primary Exclusion Criteria:

• Unstable or poorly controlled hypertension > 150/100 mm Hg

• Arterial thromboembolic events within 6 months

• Clinically significant uncontrolled cardiac disease

• Significant proteinuria at baseline

• Grade 2 or greater peripheral neuropathy

• History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710
2	University of Wake Forest Baptist Medical Center	Winston Salem	North Carolina	United States	27157-0001

Sponsors and Collaborators

• Duke University
• Hoffmann-La Roche
• Sanofi
• Genentech, Inc.

Investigators

• Principal Investigator: Hope E Uronis, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00447330
• Other Study ID Numbers: Pro00008710; 11100; 8797
• First Posted: Mar 14, 2007
• Last Update Posted: Feb 13, 2015
• Last Verified: Jul 1, 2014

• Keywords provided by Duke University: metastatic esophagogastric adenocarcinomas; ESOPHAGEAL CANCER; GASTRIC CANCER; ADENOCARCINOMA; TARGTED THERAPY; BEVACIZUMAB; CAPECITBAINE; OXALIPLATIN; METASTATIC
• Additional relevant MeSH terms: Neoplasms; Adenocarcinoma; Neoplasm Metastasis; Stomach Neoplasms; Esophageal Neoplasms; Bevacizumab; Capecitabine; Oxaliplatin

Study Results

Participant Flow

Pre-assignment Detail	81 subjects consented, 21 were screen failures, 60 subjects were considered enrolled.

Arm/Group Title	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Period Title: Overall Study
STARTED	60
COMPLETED	58
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (12)
Sex: Female, Male (Count of Participants)
Female	13 21.7%
Male	47 78.3%

Outcome Measures

1. Primary Outcome

Title	Median Progression-Free Survival (PFS)
Description	Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.
Time Frame	5 years from study start date

Outcome Measure Data

Analysis Population Description

All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.

Arm/Group Title	1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Measure Participants	49
Median (90% Confidence Interval) [survival time in months]	6.97

2. Secondary Outcome

Title	To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma
Description	Number of subjects who experienced an adverse event
Time Frame	Every 21 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Measure Participants	58
Number [participants]	56 93.3%

3. Secondary Outcome

Title	Response Rate
Description	The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.
Time Frame	Every 9 weeks for up to 1 year

Outcome Measure Data

Analysis Population Description

All eligible patients.

Arm/Group Title	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Measure Participants	60
Number (95% Confidence Interval) [percentage of participants]	41.7 69.5%

4. Secondary Outcome

Title	Median Survival
Description	Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.
Time Frame	5 years after study start date

Outcome Measure Data

Analysis Population Description

All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.

Arm/Group Title	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
Measure Participants	58
Median (90% Confidence Interval) [survival time in months]	10.51

Adverse Events

Time Frame	Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
Arm/Group Title	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Arm/Group Description	capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
All Cause Mortality
	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
	Affected / at Risk (%)	# Events
Total	33/58 (56.9%)
Blood and lymphatic system disorders
Febrile neutropenia	1/58 (1.7%)
Cardiac disorders
Cardiac arrest	1/58 (1.7%)
Cardiac disorders - Other, specify	1/58 (1.7%)
Pericardial effusion	1/58 (1.7%)
Gastrointestinal disorders
Abdominal pain	1/58 (1.7%)
Ascites	1/58 (1.7%)
Constipation	2/58 (3.4%)
Diarrhea	1/58 (1.7%)
Duodenal hemorrhage	1/58 (1.7%)
Duodenal ulcer	1/58 (1.7%)
Dysphagia	2/58 (3.4%)
Esophageal hemorrhage	1/58 (1.7%)
Esophageal obstruction	1/58 (1.7%)
Esophageal perforation	1/58 (1.7%)
Gastric perforation	2/58 (3.4%)
Gastrointestinal disorders - Other, specify	1/58 (1.7%)
Nausea	3/58 (5.2%)
Vomiting	6/58 (10.3%)
General disorders
Death NOS	1/58 (1.7%)
Fatigue	1/58 (1.7%)
Pain	3/58 (5.2%)
Infections and infestations
Infections and infestations - Other, specify	3/58 (5.2%)
Lung infection	1/58 (1.7%)
Sepsis	1/58 (1.7%)
Injury, poisoning and procedural complications
Fracture	1/58 (1.7%)
Wound dehiscence	1/58 (1.7%)
Metabolism and nutrition disorders
Anorexia	3/58 (5.2%)
Dehydration	4/58 (6.9%)
Hyponatremia	1/58 (1.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/58 (1.7%)
Generalized muscle weakness	1/58 (1.7%)
Pain in extremity	1/58 (1.7%)
Nervous system disorders
Dysphasia	1/58 (1.7%)
Nervous system disorders - Other, specify	1/58 (1.7%)
Peripheral sensory neuropathy	1/58 (1.7%)
Syncope	3/58 (5.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/58 (3.4%)
Hypoxia	1/58 (1.7%)
Respiratory, thoracic and mediastinal disorders - Other, specify	1/58 (1.7%)
Vascular disorders
Thromboembolic event	2/58 (3.4%)
Other (Not Including Serious) Adverse Events
	1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
	Affected / at Risk (%)	# Events
Total	56/58 (96.6%)
Blood and lymphatic system disorders
Anemia	6/58 (10.3%)
Blood and lymphatic system disorders - Other, specify	3/58 (5.2%)
Cardiac disorders
Sinus tachycardia	1/58 (1.7%)
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify	1/58 (1.7%)
Tinnitus	1/58 (1.7%)
Eye disorders
Blurred vision	4/58 (6.9%)
Eye disorders - Other, specify	2/58 (3.4%)
Gastrointestinal disorders
Abdominal distension	1/58 (1.7%)
Abdominal pain	7/58 (12.1%)
Anal mucositis	3/58 (5.2%)
Ascites	1/58 (1.7%)
Colitis	1/58 (1.7%)
Constipation	18/58 (31%)
Diarrhea	26/58 (44.8%)
Dry mouth	2/58 (3.4%)
Dyspepsia	1/58 (1.7%)
Dysphagia	5/58 (8.6%)
Esophageal obstruction	1/58 (1.7%)
Esophagitis	1/58 (1.7%)
Gastritis	2/58 (3.4%)
Gastrointestinal disorders - Other, specify	6/58 (10.3%)
Hemorrhoids	1/58 (1.7%)
Intra-abdominal hemorrhage	1/58 (1.7%)
Mucositis oral	6/58 (10.3%)
Nausea	28/58 (48.3%)
Oral pain	2/58 (3.4%)
Rectal hemorrhage	1/58 (1.7%)
Stomach pain	4/58 (6.9%)
Upper gastrointestinal hemorrhage	2/58 (3.4%)
Vomiting	23/58 (39.7%)
General disorders
Chills	1/58 (1.7%)
Edema limbs	4/58 (6.9%)
Facial pain	1/58 (1.7%)
Fatigue	28/58 (48.3%)
Fever	6/58 (10.3%)
General disorders and administration site conditions - Other, specify	3/58 (5.2%)
Pain	12/58 (20.7%)
Hepatobiliary disorders
Hepatic failure	1/58 (1.7%)
Hepatobiliary disorders - Other, specify	1/58 (1.7%)
Immune system disorders
Allergic reaction	1/58 (1.7%)
Infections and infestations
Infections and infestations - Other, specify	6/58 (10.3%)
Lung infection	1/58 (1.7%)
Nail infection	1/58 (1.7%)
Urinary tract infection	1/58 (1.7%)
Injury, poisoning and procedural complications
Fracture	1/58 (1.7%)
Wound dehiscence	1/58 (1.7%)
Investigations
Alanine aminotransferase increased	4/58 (6.9%)
Alkaline phosphatase increased	3/58 (5.2%)
Aspartate aminotransferase increased	5/58 (8.6%)
Blood bilirubin increased	4/58 (6.9%)
CPK increased	1/58 (1.7%)
Investigations - Other, specify	1/58 (1.7%)
Neutrophil count decreased	16/58 (27.6%)
Platelet count decreased	10/58 (17.2%)
Weight loss	10/58 (17.2%)
White blood cell decreased	3/58 (5.2%)
Metabolism and nutrition disorders
Anorexia	24/58 (41.4%)
Dehydration	6/58 (10.3%)
Hyperglycemia	2/58 (3.4%)
Hyperkalemia	1/58 (1.7%)
Hypoalbuminemia	2/58 (3.4%)
Hypocalcemia	1/58 (1.7%)
Hypokalemia	4/58 (6.9%)
Hyponatremia	2/58 (3.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/58 (6.9%)
Arthritis	1/58 (1.7%)
Back pain	4/58 (6.9%)
Buttock pain	1/58 (1.7%)
Chest wall pain	6/58 (10.3%)
Generalized muscle weakness	3/58 (5.2%)
Joint effusion	1/58 (1.7%)
Musculoskeletal and connective tissue disorder - Other, specify	6/58 (10.3%)
Myalgia	1/58 (1.7%)
Neck pain	1/58 (1.7%)
Pain in extremity	6/58 (10.3%)
Nervous system disorders
Depressed level of consciousness	1/58 (1.7%)
Dizziness	9/58 (15.5%)
Dysgeusia	9/58 (15.5%)
Dysphasia	3/58 (5.2%)
Headache	4/58 (6.9%)
Nervous system disorders - Other, specify	5/58 (8.6%)
Peripheral motor neuropathy	2/58 (3.4%)
Peripheral sensory neuropathy	32/58 (55.2%)
Syncope	1/58 (1.7%)
Tremor	2/58 (3.4%)
Psychiatric disorders
Anxiety	2/58 (3.4%)
Confusion	1/58 (1.7%)
Depression	4/58 (6.9%)
Insomnia	4/58 (6.9%)
Personality change	1/58 (1.7%)
Renal and urinary disorders
Hemoglobinuria	1/58 (1.7%)
Proteinuria	1/58 (1.7%)
Renal and urinary disorders - Other, specify	2/58 (3.4%)
Urinary frequency	2/58 (3.4%)
Urinary retention	1/58 (1.7%)
Urinary tract pain	1/58 (1.7%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	2/58 (3.4%)
Cough	9/58 (15.5%)
Dyspnea	8/58 (13.8%)
Epistaxis	2/58 (3.4%)
Hiccups	1/58 (1.7%)
Pharyngolaryngeal pain	2/58 (3.4%)
Pleural effusion	2/58 (3.4%)
Pneumonitis	1/58 (1.7%)
Respiratory, thoracic and mediastinal disorders - Other, specify	2/58 (3.4%)
Sinus disorder	5/58 (8.6%)
Voice alteration	1/58 (1.7%)
Skin and subcutaneous tissue disorders
Dry skin	7/58 (12.1%)
Hyperhidrosis	1/58 (1.7%)
Nail loss	1/58 (1.7%)
Palmar-plantar erythrodysesthesia syndrome	17/58 (29.3%)
Purpura	1/58 (1.7%)
Rash acneiform	2/58 (3.4%)
Rash maculo-papular	6/58 (10.3%)
Skin and subcutaneous tissue disorders - Other, specify	6/58 (10.3%)
Skin hyperpigmentation	4/58 (6.9%)
Skin ulceration	1/58 (1.7%)
Vascular disorders
Hypertension	8/58 (13.8%)
Hypotension	2/58 (3.4%)
Thromboembolic event	4/58 (6.9%)
Vascular disorders - Other, specify	2/58 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.