Trial Outcomes & Findings for A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®. (NCT NCT04408989)
NCT ID: NCT04408989
Last Updated: 2024-09-19
Results Overview
Compare the pharmacokinetic (PK) profiles of the 3 arms (AUC\[0-∞\])
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
114 participants
Primary outcome timeframe
Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
MB02-SP (Bevacizumab Biosimilar)
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
39
|
38
|
|
Overall Study
COMPLETED
|
37
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
MB02-SP (Bevacizumab Biosimilar)
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®.
Baseline characteristics by cohort
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
32.04 years
STANDARD_DEVIATION 10.76 • n=4 Participants
|
|
Sex/Gender, Customized
Only male subjects
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
BMI
|
24.94 kg/m^2
STANDARD_DEVIATION 2.396 • n=5 Participants
|
24.34 kg/m^2
STANDARD_DEVIATION 2.162 • n=7 Participants
|
24.79 kg/m^2
STANDARD_DEVIATION 2.786 • n=5 Participants
|
24.68 kg/m^2
STANDARD_DEVIATION 2.47 • n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dosePopulation: The PK population included all subjects who received the full dose of MB02-SP, MB02-DM or US-Avastin®, did not had any major protocol deviations, and had evaluable PK data for at least one timepoint
Compare the pharmacokinetic (PK) profiles of the 3 arms (AUC\[0-∞\])
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Pharmacokinetics (PK) - (AUC[0-∞])
|
7500000 h*ng/ml
Geometric Coefficient of Variation 12.3
|
8000000 h*ng/ml
Geometric Coefficient of Variation 15.8
|
7520000 h*ng/ml
Geometric Coefficient of Variation 14.4
|
PRIMARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dosePopulation: The PK population included all subjects who received the full dose of MB02-SP, MB02-DM or US-Avastin®, did not had any major protocol deviations, and had evaluable PK data for at least one timepoint
Compare the pharmacokinetic (PK) profiles of the 3 arms (Cmax)
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Pharmacokinetics (PK) - (Cmax)
|
25600 ng/ml
Geometric Coefficient of Variation 15.7
|
27400 ng/ml
Geometric Coefficient of Variation 14.9
|
26100 ng/ml
Geometric Coefficient of Variation 16.6
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-doseEvaluation of all other PK parameters (tmax) tmax = time of maximum observed serum concentration
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Other PK Parameters (Tmax)
|
4.02 hours
Interval 1.5 to 8.0
|
5.00 hours
Interval 1.5 to 6.3
|
5.00 hours
Interval 1.52 to 12.0
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-doseEvaluation of all other PK parameters (AUC\[0 t\]) AUC(0-t) = AUC from time zero to the time of last quantifiable concentration
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Other PK Parameters (AUC[0 t])
|
7010000 h*ng/ml
Geometric Coefficient of Variation 14.8
|
7550000 h*ng/ml
Geometric Coefficient of Variation 16.9
|
7110000 h*ng/ml
Geometric Coefficient of Variation 15.4
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-doseEvaluation of all other PK parameters (CL) CL = total body clearance of drug after intravenous administration
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Other PK Parameters (CL)
|
0.0103 L/h
Geometric Coefficient of Variation 13.9
|
0.00975 L/h
Geometric Coefficient of Variation 15.2
|
0.0104 L/h
Geometric Coefficient of Variation 16.5
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-doseEvaluation of all other PK parameters (t1/2) t½ = apparent serum terminal elimination half-life
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Other PK Parameters (t1/2)
|
390 hours
Geometric Coefficient of Variation 17.2
|
393 hours
Geometric Coefficient of Variation 11.1
|
396 hours
Geometric Coefficient of Variation 14.4
|
SECONDARY outcome
Timeframe: Days -1, 14, 28, 56 and 78Population: The safety population included all subjects exposed to MB02-SP, MB02-DM or US-Avastin®, and had at least one post dose safety assessment
Number of participants with anti-bevacizumab antiboides (ADA), including neutralizing antibodies (Nab). Subjects who tested positive at baseline are not included here.
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Immunogenicity
ADA positive
|
8 participants
|
13 participants
|
9 participants
|
|
Immunogenicity
nAb positive
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 100Population: The safety population included all subjects exposed to MB02-SP, MB02-DM or US-Avastin®, and had at least one post dose safety assessment
Number of participants who reported Treatment-related Adverse Events using the CTCAE v5.0 criteria
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Safety (Number of Participants Reporting Treatment-related Adverse Events)
Subjects with TEAEs
|
24 Participants
|
23 Participants
|
29 Participants
|
|
Safety (Number of Participants Reporting Treatment-related Adverse Events)
Subjects with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety (Number of Participants Reporting Treatment-related Adverse Events)
Subjects discontinued due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety (Number of Participants Reporting Treatment-related Adverse Events)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 100Population: The safety population included all subjects exposed to MB02-SP, MB02-DM or US-Avastin®, and had at least one post dose safety assessment
Treatment-related Adverse Events based on the CTCAE v5.0 criteria reported by the study participants
Outcome measures
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 Participants
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Safety (Treatment-related Adverse Events)
TEAEs
|
42 events
|
58 events
|
59 events
|
|
Safety (Treatment-related Adverse Events)
Related TEAEs (possibly, probably and related TEAES)
|
12 events
|
9 events
|
6 events
|
|
Safety (Treatment-related Adverse Events)
Unrelated TEAES (unlikely and not related)
|
30 events
|
49 events
|
53 events
|
|
Safety (Treatment-related Adverse Events)
Mild (Grade 1) TEAES
|
39 events
|
55 events
|
50 events
|
|
Safety (Treatment-related Adverse Events)
Moderate (Grade 2) TEAES
|
3 events
|
3 events
|
9 events
|
|
Safety (Treatment-related Adverse Events)
Severe (Grade 3) TEAES
|
0 events
|
0 events
|
0 events
|
|
Safety (Treatment-related Adverse Events)
Life-Threatening (Grade 4) TEAEs
|
0 events
|
0 events
|
0 events
|
Adverse Events
MB02-SP (Bevacizumab Biosimilar)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
MB02-DM (Bevacizumab Biosimilar)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
US Licenced Avastin®
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MB02-SP (Bevacizumab Biosimilar)
n=37 participants at risk
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-SP: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
MB02-DM (Bevacizumab Biosimilar)
n=39 participants at risk
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
MB02-DM: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
US Licenced Avastin®
n=38 participants at risk
Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
US licenced Avastin®: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 3 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
15.4%
6/39 • Number of events 7 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
18.4%
7/38 • Number of events 8 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
3/37 • Number of events 3 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
10.3%
4/39 • Number of events 4 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
23.7%
9/38 • Number of events 10 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
4/37 • Number of events 4 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
2.6%
1/39 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
7.9%
3/38 • Number of events 4 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/37 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
10.3%
4/39 • Number of events 5 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
2.6%
1/38 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/37 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
7.7%
3/39 • Number of events 3 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
5.3%
2/38 • Number of events 2 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.1%
3/37 • Number of events 3 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
2.6%
1/39 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
2.6%
1/38 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
|
General disorders
Catheter site bruise
|
2.7%
1/37 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
7.7%
3/39 • Number of events 3 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
2.6%
1/38 • Number of events 1 • Study duration (Day 1 - Day 100)
Coded according to Medical Dictionary for Regulatory Activities (version 24.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place