Trial Outcomes & Findings for Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00335829)
NCT ID: NCT00335829
Last Updated: 2021-08-13
Results Overview
This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Time through study completion, an average of 1 year
Results posted on
2021-08-13
Participant Flow
Patients with a diagnosis of unresectable hepatocellular carcinoma (HCC) were enrolled on this protocol to receive a combination of intravenous bevacizumab and transarterial chemoembolization (TACE) therapy. A total of 26 patients were enrolled on protocol; 10 patients at Northwestern University and 16 at Johns Hopkins University.
Participant milestones
| Measure |
Single Arm, Received Bevacizumab and TACE
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Received Bevacizumab
|
26
|
|
Overall Study
Received First TACE
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Single Arm, Received Bevacizumab and TACE
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Single Arm, Received Bevacizumab and TACE
n=26 Participants
bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time through study completion, an average of 1 yearPopulation: PFS analysis was not conducted. No data were collected for this Outcome Measure
This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months and 1 yearTime to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Time to Tumor Progression (TTP) of Targeted Lesions
|
NA months
Among the targeted lesions, the majority had no evidence of progression at 6 months (86%) or at 1 year (53%). The median TTP of the targeted lesions from the start of therapy was not reached at last follow-up of 1 year.
|
SECONDARY outcome
Timeframe: 1 yearTTP of nontargeted lesions assessed via Kaplan-Meier methodology.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
TTP of Nontargeted Lesions Within the Liver
|
9.1 months
Interval 6.5 to 9.1
|
SECONDARY outcome
Timeframe: 1 yearOverall TTP assessed via Kaplan-Meier methodology.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Overall TTP
|
7.2 months
Interval 5.8 to 9.1
|
SECONDARY outcome
Timeframe: 6 months and 1 yearOverall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
TTP Rate at 6 Months and 1 Year
TTP rate at 1 year
|
23 percentage of participants
Interval 9.0 to 60.0
|
|
TTP Rate at 6 Months and 1 Year
TTP rate at 6 months
|
65 percentage of participants
Interval 47.0 to 90.0
|
SECONDARY outcome
Timeframe: 1 yearOS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Overall Survival (OS)
OS from start of therapy
|
10.8 months
Interval 4.8 to 24.7
|
|
Overall Survival (OS)
OS from date of diagnosis
|
23.6 months
Interval 12.8 to 31.5
|
SECONDARY outcome
Timeframe: 6 monthsEfficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease (SD)
|
15 Participants
|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response (CR)
|
0 Participants
|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response (PR)
|
8 Participants
|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease (PD)
|
0 Participants
|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Overall response rate (CR + PR)
|
8 Participants
|
|
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Disease control rate (CR + PR + SD)
|
23 Participants
|
SECONDARY outcome
Timeframe: 6 monthsEfficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria: Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=23 Participants
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Response Rate - Based on Tumor Enhancement
Complete Response (CR)
|
4 Participants
|
|
Response Rate - Based on Tumor Enhancement
Partial Response (PR)
|
10 Participants
|
|
Response Rate - Based on Tumor Enhancement
Overall response rate (CR + PR)
|
14 Participants
|
|
Response Rate - Based on Tumor Enhancement
Disease control rate (CR + PR + SD)
|
23 Participants
|
|
Response Rate - Based on Tumor Enhancement
Stable Disease (SD)
|
9 Participants
|
|
Response Rate - Based on Tumor Enhancement
Progressive Disease (PD)
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 pre-TACE - 2 weeksSafety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=24 Adverse events
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Coagulation
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Weight loss
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Esophageal varices
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Elevated ALT
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Fatigue
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Ascites
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Anorexia
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Nausea
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Vomiting
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Elevated AST
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Hyperbilirubinemia
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Hyponatremia
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Encephalopathy
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Right upper quadrant pain
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Proteinuria
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Respiratory
|
1 adverse events
|
SECONDARY outcome
Timeframe: Cycle 1 post-TACE - 5 weeksPopulation: 1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment.
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=151 Adverse events
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Ischemia
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Coagulation
|
10 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Night sweats
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Weight loss
|
6 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Ascites
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Hyperglycemia
|
8 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Hypocalcemia
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Hypokalemia
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Hyponatremia
|
7 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Psychosis
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Abdominal pain, not otherwise specified (NOS)
|
6 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Epigastric pain
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Right upper quadrant pain
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Anemia
|
10 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Leukocytopenia
|
7 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Lymphopenia
|
8 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Edema
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Fatigue
|
12 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Anorexia
|
11 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Nausea
|
4 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Vomiting
|
6 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
HEENT
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Elevated ALT
|
7 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Elevated AST
|
7 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Hyperbilirubinemia
|
6 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Liver failure
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Cellulitis
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Colangitis
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Delirium
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Chest pain
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Pain - other
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Dyspnea
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Acute renal failure
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Proteinuria
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Respiratory
|
3 adverse events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed.
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy
Outcome measures
| Measure |
Single Arm, Received Bevacizumab and TACE
n=103 Adverse events
Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
|
|---|---|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Right upper quadrant pain
|
4 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Pain - other
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Dyspnea
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Leukocytopenia
|
7 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Lymphopenia
|
12 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Heart failure
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Edema
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Coagulation
|
5 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Fatigue
|
11 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Weight loss
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Dermatologic
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Endocrine
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Ascites
|
3 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Anorexia
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Duodenal perforation
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Nausea
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Vomiting
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Elevated ALT
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Elevated AST
|
6 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Hyperbilirubinemia
|
4 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Clostridium difficile
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Hyperglycemia
|
11 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Hypocalcemia
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Hypokalemia
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Hyponatremia
|
4 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Fracture
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Cord compression
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Stroke
|
1 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Proteinuria
|
2 adverse events
|
|
Safety and Treatment Toxicity - Cycles 2 and 3
Respiratory
|
5 adverse events
|
Adverse Events
Single Arm, Received Bevacizumab and TACE
Serious events: 6 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Arm, Received Bevacizumab and TACE
n=26 participants at risk
bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion
|
|---|---|
|
Infections and infestations
Clostridium difficile infection
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Nervous system disorders
Cerebral infarct
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Duodenal perforation
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Liver failure
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Cardiac disorders
Heart failure
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Esophageal varices
|
3.8%
1/26 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Single Arm, Received Bevacizumab and TACE
n=26 participants at risk
bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
10/26 • Number of events 10 • 6 months
|
|
Investigations
Leukocytopenia
|
26.9%
7/26 • Number of events 14 • 6 months
|
|
Investigations
Lymphopenia
|
46.2%
12/26 • Number of events 20 • 6 months
|
|
General disorders
Edema
|
11.5%
3/26 • Number of events 5 • 6 months
|
|
Investigations
Coagulation/Elevated INR
|
38.5%
10/26 • Number of events 15 • 6 months
|
|
General disorders
Fatigue
|
46.2%
12/26 • Number of events 25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
2/26 • Number of events 2 • 6 months
|
|
General disorders
Weight loss
|
23.1%
6/26 • Number of events 8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
11.5%
3/26 • Number of events 3 • 6 months
|
|
Endocrine disorders
Endocrine
|
7.7%
2/26 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
11.5%
3/26 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
42.3%
11/26 • Number of events 14 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
19.2%
5/26 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
6/26 • Number of events 9 • 6 months
|
|
Investigations
Elevated ALT
|
26.9%
7/26 • Number of events 10 • 6 months
|
|
Investigations
Elevated AST
|
26.9%
7/26 • Number of events 15 • 6 months
|
|
Investigations
Hyperbilirubinemia
|
23.1%
6/26 • Number of events 13 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholangitis
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.3%
11/26 • Number of events 19 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.5%
3/26 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
2/26 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.9%
7/26 • Number of events 11 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Nervous system disorders
Spinal cord compression
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Delirium
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Nervous system disorders
Encephalopathy
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Psychosis
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
6/26 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Epigastric pain
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Right upper quadrant pain
|
15.4%
4/26 • Number of events 8 • 6 months
|
|
General disorders
Chest pain
|
7.7%
2/26 • Number of events 2 • 6 months
|
|
General disorders
Pain - other
|
11.5%
3/26 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
2/26 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
2/26 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
19.2%
5/26 • Number of events 9 • 6 months
|
Additional Information
Jeff Geschwind, MD
Johns Hopkins, Interventional Radiology
Phone: 410-614-6597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place