Trial Outcomes & Findings for Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus) (NCT NCT01589185)
NCT ID: NCT01589185
Last Updated: 2020-04-24
Results Overview
A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
At Day 28 post infusion (Day 0)
Results posted on
2020-04-24
Participant Flow
Recruitment locations: Intensive Care Units. First subject enrolled: 16-May-2012. Last subject completed: 06-Sep-2016. The study was on administrative hold from 20-Nov-2012 to 24-Dec-2014.
Eligible patients were randomized based on evidence of severe pneumonia caused by S. aureus. All patients enrolled were intubated.
Participant milestones
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
10
|
8
|
16
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
5
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
3
|
0
|
Baseline Characteristics
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
Baseline characteristics by cohort
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=10 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 17.02 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 13.62 • n=4 Participants
|
52.1 years
STANDARD_DEVIATION 16.23 • n=21 Participants
|
56.6 years
STANDARD_DEVIATION 14.77 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
38 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
46 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
6 participants
n=4 Participants
|
16 participants
n=21 Participants
|
43 participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Type of Pneumonia
CABP
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Type of Pneumonia
VABP
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Type of Pneumonia
HABP
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Type of S. aureus Infection
MRSA
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Type of S. aureus Infection
MSSA
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Type of S. aureus Infection
Not confirmed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
BMI
|
32.6 kg/m^2
STANDARD_DEVIATION 9.14 • n=5 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 7.3 • n=7 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 6.15 • n=5 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 3.88 • n=4 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 5.39 • n=21 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 6.32 • n=10 Participants
|
|
Pa02/Fi02 Ratio
|
146.7 ratio
STANDARD_DEVIATION 30.7 • n=5 Participants
|
173.7 ratio
STANDARD_DEVIATION 38.36 • n=7 Participants
|
138.8 ratio
STANDARD_DEVIATION 53.56 • n=5 Participants
|
148.4 ratio
STANDARD_DEVIATION 34.49 • n=4 Participants
|
140.7 ratio
STANDARD_DEVIATION 40.7 • n=21 Participants
|
147.8 ratio
STANDARD_DEVIATION 41.32 • n=10 Participants
|
|
SOFA Score
|
6.8 units on a scale (score)
STANDARD_DEVIATION 1.64 • n=5 Participants
|
8.8 units on a scale (score)
STANDARD_DEVIATION 3.45 • n=7 Participants
|
5.6 units on a scale (score)
STANDARD_DEVIATION 1.51 • n=5 Participants
|
6.8 units on a scale (score)
STANDARD_DEVIATION 1.72 • n=4 Participants
|
6.8 units on a scale (score)
STANDARD_DEVIATION 2.86 • n=21 Participants
|
6.9 units on a scale (score)
STANDARD_DEVIATION 2.62 • n=10 Participants
|
|
APACHE II Score
|
18.3 units on a scale (score)
STANDARD_DEVIATION 3.01 • n=5 Participants
|
21.5 units on a scale (score)
STANDARD_DEVIATION 5.21 • n=7 Participants
|
17.9 units on a scale (score)
STANDARD_DEVIATION 4.15 • n=5 Participants
|
19.5 units on a scale (score)
STANDARD_DEVIATION 3.7 • n=4 Participants
|
17.5 units on a scale (score)
STANDARD_DEVIATION 4.9 • n=21 Participants
|
18.7 units on a scale (score)
STANDARD_DEVIATION 4.48 • n=10 Participants
|
|
CPIS Score
|
8.3 units on a scale (score)
STANDARD_DEVIATION 1.63 • n=5 Participants
|
9.6 units on a scale (score)
STANDARD_DEVIATION 2.26 • n=7 Participants
|
9.6 units on a scale (score)
STANDARD_DEVIATION 2.26 • n=5 Participants
|
9.6 units on a scale (score)
STANDARD_DEVIATION 3.7 • n=4 Participants
|
9.8 units on a scale (score)
STANDARD_DEVIATION 1.28 • n=21 Participants
|
9.6 units on a scale (score)
STANDARD_DEVIATION 1.58 • n=10 Participants
|
PRIMARY outcome
Timeframe: At Day 28 post infusion (Day 0)Population: The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.
Outcome measures
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=9 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
All Treatment Group
n=31 Participants
Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
|
|---|---|---|---|---|---|---|
|
Efficacy Endpoint: All-Cause Mortality by Day 28
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Patients who died during the specified timepoints (by EOS), up to day 107Population: The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.
Outcome measures
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=9 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
All Treatment Group
Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
|
|---|---|---|---|---|---|---|
|
Efficacy: All-Cause Mortality (End Of Study [EOS])
Survived on or before EOS
|
5 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
15 Participants
|
—
|
|
Efficacy: All-Cause Mortality (End Of Study [EOS])
Died on or before EOS
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Patients who died during the specified timepoints (Day 14)Population: The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.
Outcome measures
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=9 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
All Treatment Group
Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
|
|---|---|---|---|---|---|---|
|
Efficacy: All-Cause Mortality (Day 14)
Died on or before Day 14
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Efficacy: All-Cause Mortality (Day 14)
Survived on or before Day 14
|
5 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Patients who died during the specified timepoints (Day 7)Population: The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.
Outcome measures
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=9 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
All Treatment Group
Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
|
|---|---|---|---|---|---|---|
|
Efficacy: All-Cause Mortality (Day 7)
Died on or before Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Efficacy: All-Cause Mortality (Day 7)
Survived on or before Day 7
|
6 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Patients who died during the specified timepoints (Day 21)Population: The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.
Outcome measures
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 Participants
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 Participants
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=9 Participants
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 Participants
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 Participants
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
All Treatment Group
Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
|
|---|---|---|---|---|---|---|
|
Efficacy: All-Cause Mortality (Day 21)
Died on or before Day 21
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Efficacy: All-Cause Mortality (Day 21)
Survived on or before Day 21
|
5 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
16 Participants
|
—
|
Adverse Events
KBSA301, a Monoclonal Antibody Dose 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
KBSA301, a Monoclonal Antibody Dose 2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
KBSA301, a Monoclonal Antibody Dose 3
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
KBSA301, a Monoclonal Antibody Dose 4
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 participants at risk
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 participants at risk
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=10 participants at risk
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 participants at risk
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 participants at risk
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Abscess neck
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Wound infection staphylococcal
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Coma
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Shock hemorrhage
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Multi-organ failure
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Injury, poisoning and procedural complications
Post-procedural haemorrhage
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
Other adverse events
| Measure |
KBSA301, a Monoclonal Antibody Dose 1
n=6 participants at risk
1 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 2
n=8 participants at risk
3 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 3
n=10 participants at risk
10 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
KBSA301, a Monoclonal Antibody Dose 4
n=8 participants at risk
20 mg/kg KBSA301
KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
|
Placebo
n=16 participants at risk
KBSA301-placebo
Placebo: Placebo administered as a single intravenous infusion
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
37.5%
3/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
2/6 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
37.5%
3/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
4/16 • Number of events 4 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Retroperitoneal oedema
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Chest pain
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Inflammation
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Oedema
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
37.5%
3/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Enterobacter tracheobronchitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Haematoma infection
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
50.0%
5/10 • Number of events 6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
18.8%
3/16 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Injury, poisoning and procedural complications
Electrical burn
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood potassium decreased
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
37.5%
3/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
30.0%
3/10 • Number of events 4 • From time of treatment to day 107.
Standard definitions were used.
|
50.0%
4/8 • Number of events 4 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Blood sodium increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Platelet count increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
37.5%
3/8 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Prothrombin level abnormal
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Cerebral salt-wasting syndrome
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
20.0%
2/10 • Number of events 4 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
10.0%
1/10 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
18.8%
3/16 • Number of events 3 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
25.0%
2/8 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
2/16 • Number of events 2 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/16 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/6 • From time of treatment to day 107.
Standard definitions were used.
|
12.5%
1/8 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/10 • From time of treatment to day 107.
Standard definitions were used.
|
0.00%
0/8 • From time of treatment to day 107.
Standard definitions were used.
|
6.2%
1/16 • Number of events 1 • From time of treatment to day 107.
Standard definitions were used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60