Trial Outcomes & Findings for Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC) (NCT NCT00617981)
NCT ID: NCT00617981
Last Updated: 2024-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
701 participants
Primary outcome timeframe
3 years
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
ThermoDox + RFA
ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
354
|
347
|
|
Overall Study
COMPLETED
|
244
|
245
|
|
Overall Study
NOT COMPLETED
|
110
|
102
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)
Baseline characteristics by cohort
| Measure |
ThermoDox + RFA
n=354 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=347 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
Total
n=701 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Age, Customized
40-<45
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Age, Customized
45-<50
|
18 participants
n=5 Participants
|
25 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Age, Customized
50-<55
|
42 participants
n=5 Participants
|
44 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Age, Customized
55-<60
|
57 participants
n=5 Participants
|
50 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Age, Customized
60-<65
|
65 participants
n=5 Participants
|
64 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Age, Customized
65-<70
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Age, Customized
70-<75
|
51 participants
n=5 Participants
|
42 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Age, Customized
75-<80
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Age, Customized
80-<85
|
19 participants
n=5 Participants
|
13 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
85+
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
Missing
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
267 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
530 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 participants
n=5 Participants
|
26 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
83 participants
n=5 Participants
|
91 participants
n=7 Participants
|
174 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Taiwanese
|
66 participants
n=5 Participants
|
62 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
115 participants
n=5 Participants
|
125 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
40 participants
n=5 Participants
|
32 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
68 participants
n=5 Participants
|
63 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
16 participants
n=5 Participants
|
8 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
32 participants
n=5 Participants
|
17 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
China
|
104 participants
n=5 Participants
|
104 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
82 participants
n=5 Participants
|
92 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
ThermoDox + RFA
n=354 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=347 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause
|
13.97 Time to Progression (months)
Interval 11.47 to 19.26
|
13.87 Time to Progression (months)
Interval 11.14 to 16.69
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
ThermoDox + RFA
n=354 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=347 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Overall Survival as Measured by Time From Randomization to Death or the End of the Study.
|
189 Participants (Deaths)
|
188 Participants (Deaths)
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-treat (ITT) population
Number of participants with significant symptom deterioration, defined as greater than or equal to 4-point increase from baseline in the eight-item Functional Assessment of Cancer Therapy-Hepatobiliary Symptom Index.
Outcome measures
| Measure |
ThermoDox + RFA
n=354 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=347 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Number of Participants With Definite Worsening as Per Patient-Reported Outcomes
|
53 participants
|
60 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intent-to-treat (ITT) population
Number of participants with local progression in the intent-to-treat (ITT) population.
Outcome measures
| Measure |
ThermoDox + RFA
n=354 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=347 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Number of Participants With Local Recurrence
|
58 participants
|
55 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Incidence of treatment-related adverse events (≥ 5% of patients in either group; safety population)
Outcome measures
| Measure |
ThermoDox + RFA
n=343 Participants
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=344 Participants
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Evaluation of Safety
|
83 percentage of overall incidence
|
35 percentage of overall incidence
|
Adverse Events
ThermoDox + RFA
Serious events: 118 serious events
Other events: 327 other events
Deaths: 0 deaths
Sham + RFA
Serious events: 37 serious events
Other events: 301 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ThermoDox + RFA
n=343 participants at risk
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=334 participants at risk
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
16.3%
56/343
|
0.00%
0/334
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
19/343
|
0.00%
0/334
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.6%
9/343
|
0.00%
0/334
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.87%
3/343
|
0.00%
0/334
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/343
|
0.30%
1/334
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.58%
2/343
|
0.60%
2/334
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.29%
1/343
|
0.90%
3/334
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.29%
1/343
|
0.60%
2/334
|
|
Gastrointestinal disorders
Ascites
|
0.58%
2/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
2/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/343
|
0.60%
2/334
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Gastric Varices Haemorrhage
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/343
|
0.30%
1/334
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Localised Intraabdominal Fluid Collection
|
0.00%
0/343
|
0.30%
1/334
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.29%
1/343
|
0.00%
0/334
|
|
Gastrointestinal disorders
Portal Hypertensive Gastropathy
|
0.00%
0/343
|
0.30%
1/334
|
|
Gastrointestinal disorders
Stress Ulcer
|
0.00%
0/343
|
0.30%
1/334
|
|
Infections and infestations
Pneumonia
|
0.29%
1/343
|
0.60%
2/334
|
|
Infections and infestations
Cellulitis
|
0.58%
2/343
|
0.00%
0/334
|
|
Infections and infestations
Liver Abscess
|
0.58%
2/343
|
0.00%
0/334
|
|
Infections and infestations
Neutropenic Sepsis
|
0.58%
2/343
|
0.00%
0/334
|
|
Infections and infestations
Peritonitis Bacterial
|
0.58%
2/343
|
0.00%
0/334
|
|
Infections and infestations
Sepsis
|
0.29%
1/343
|
0.30%
1/334
|
|
Infections and infestations
Septic Shock
|
0.29%
1/343
|
0.30%
1/334
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/343
|
0.30%
1/334
|
|
Infections and infestations
Anal Abscess
|
0.29%
1/343
|
0.00%
0/334
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/343
|
0.30%
1/334
|
|
Infections and infestations
Furuncle
|
0.29%
1/343
|
0.00%
0/334
|
|
Infections and infestations
Gastritis Viral
|
0.29%
1/343
|
0.00%
0/334
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/343
|
0.30%
1/334
|
|
Infections and infestations
Infection
|
0.29%
1/343
|
0.00%
0/334
|
|
Infections and infestations
Salmonella Sepsis
|
0.29%
1/343
|
0.00%
0/334
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.00%
0/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Hepatic Rupture
|
0.87%
3/343
|
0.00%
0/334
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.29%
1/343
|
0.60%
2/334
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.58%
2/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.29%
1/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.29%
1/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Biloma
|
0.00%
0/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Hepatic Function Abnormal
|
0.29%
1/343
|
0.00%
0/334
|
|
Injury, poisoning and procedural complications
Hypotension
|
0.00%
0/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Puncture Site Haemorrhage
|
0.00%
0/343
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.29%
1/343
|
0.00%
0/334
|
|
Injury, poisoning and procedural complications
Wound Haemorrhage
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
Neutrophil Count Decreased
|
2.6%
9/343
|
0.00%
0/334
|
|
Investigations
Alanine Aminotransferase Increased
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
Blood Bilirubin Increased
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
Haemoglobin Decreased
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
Platelet Count Decreased
|
0.29%
1/343
|
0.00%
0/334
|
|
Investigations
White Blood Cell Count Decreased
|
0.29%
1/343
|
0.00%
0/334
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.58%
2/343
|
0.30%
1/334
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/343
|
0.60%
2/334
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/343
|
0.30%
1/334
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/343
|
0.30%
1/334
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.29%
1/343
|
0.00%
0/334
|
|
Hepatobiliary disorders
Jaundice
|
0.29%
1/343
|
0.00%
0/334
|
|
Hepatobiliary disorders
Liver Disorder
|
0.29%
1/343
|
0.00%
0/334
|
|
Hepatobiliary disorders
Liver Injury
|
0.00%
0/343
|
0.30%
1/334
|
|
General disorders
Pyrexia
|
0.29%
1/343
|
0.60%
2/334
|
|
General disorders
Multi-organ Failure
|
0.00%
0/343
|
0.60%
2/334
|
|
General disorders
Asthenia
|
0.00%
0/343
|
0.30%
1/334
|
|
General disorders
Hyperpyrexia
|
0.29%
1/343
|
0.00%
0/334
|
|
General disorders
Oedema Peripheral
|
0.29%
1/343
|
0.00%
0/334
|
|
Nervous system disorders
Hepatic encephalopthy
|
0.29%
1/343
|
0.30%
1/334
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/343
|
0.30%
1/334
|
|
Nervous system disorders
Convulsion
|
0.29%
1/343
|
0.00%
0/334
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.29%
1/343
|
0.00%
0/334
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.29%
1/343
|
0.00%
0/334
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/343
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.58%
2/343
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/343
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/343
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.29%
1/343
|
0.00%
0/334
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.29%
1/343
|
0.00%
0/334
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.58%
2/343
|
0.00%
0/334
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/343
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/343
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/343
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/343
|
0.00%
0/334
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.29%
1/343
|
0.00%
0/334
|
|
Cardiac disorders
Myocardial Infarction
|
0.58%
2/343
|
0.00%
0/334
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/343
|
0.30%
1/334
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/343
|
0.30%
1/334
|
|
Cardiac disorders
Myocardial Rupture
|
0.00%
0/343
|
0.30%
1/334
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/343
|
0.30%
1/334
|
|
Renal and urinary disorders
Acute Prerenal Failure
|
0.29%
1/343
|
0.00%
0/334
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.29%
1/343
|
0.00%
0/334
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.29%
1/343
|
0.00%
0/334
|
|
Psychiatric disorders
Delirium Tremens
|
0.29%
1/343
|
0.00%
0/334
|
|
Psychiatric disorders
Mood Altered
|
0.29%
1/343
|
0.00%
0/334
|
|
Vascular disorders
Hypotension
|
0.29%
1/343
|
0.00%
0/334
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/343
|
0.30%
1/334
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/343
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Thrombosis
|
0.29%
1/343
|
0.00%
0/334
|
|
Surgical and medical procedures
Biliary Drainage
|
0.00%
0/343
|
0.30%
1/334
|
Other adverse events
| Measure |
ThermoDox + RFA
n=343 participants at risk
ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
|
Sham + RFA
n=334 participants at risk
Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion
|
|---|---|---|
|
Vascular disorders
Hypertension
|
5.2%
18/343
|
5.1%
17/334
|
|
Renal and urinary disorders
Haematuria
|
3.8%
13/343
|
6.9%
23/334
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.3%
32/343
|
3.9%
13/334
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
26/343
|
14.7%
49/334
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
8.2%
28/343
|
11.7%
39/334
|
|
Injury, poisoning and procedural complications
Wound Complication
|
9.6%
33/343
|
9.9%
33/334
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.4%
173/343
|
0.60%
2/334
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.4%
87/343
|
1.8%
6/334
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.3%
73/343
|
1.5%
5/334
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
18/343
|
0.60%
2/334
|
|
General disorders
Pyrexia
|
16.3%
56/343
|
29.3%
98/334
|
|
General disorders
Fatigue
|
5.8%
20/343
|
4.2%
14/334
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.4%
70/343
|
21.0%
70/334
|
|
Investigations
Alanine Aminotransferase Increased
|
17.8%
61/343
|
18.6%
62/334
|
|
Investigations
Blood Bilirubin Increased
|
8.5%
29/343
|
11.7%
39/334
|
|
Investigations
White Blood Cell Count Decreased
|
14.0%
48/343
|
3.6%
12/334
|
|
Investigations
Neutrophil Count Decreased
|
11.1%
38/343
|
2.7%
9/334
|
|
Investigations
Platelet Count Decreased
|
5.8%
20/343
|
6.0%
20/334
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.5%
19/343
|
5.1%
17/334
|
|
Investigations
Neutrophil Count Increased
|
7.0%
24/343
|
2.4%
8/334
|
|
Investigations
White Blood Cell Count Increased
|
7.0%
24/343
|
1.5%
5/334
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.6%
50/343
|
18.6%
62/334
|
|
Gastrointestinal disorders
Nausea
|
15.5%
53/343
|
12.9%
43/334
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
12.8%
44/343
|
13.2%
44/334
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
35/343
|
8.4%
28/334
|
|
Gastrointestinal disorders
Constipation
|
6.1%
21/343
|
4.5%
15/334
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.4%
15/343
|
5.1%
17/334
|
Additional Information
Nicholas Borys, M.D. Senior Vice President and Chief Medical Officer
Celsion Corporation
Phone: 609-896-9100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60