Trial Outcomes & Findings for Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma (NCT NCT00761280)
NCT ID: NCT00761280
Last Updated: 2014-11-14
Results Overview
Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
24 months
Results posted on
2014-11-14
Participant Flow
Participant milestones
| Measure |
Trabedersen 10 µM
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Randomization to First Dose
STARTED
|
14
|
13
|
|
Randomization to First Dose
Catheter Surgery
|
13
|
0
|
|
Randomization to First Dose
First Dose of Study Drug / Chemotherapy
|
12
|
11
|
|
Randomization to First Dose
COMPLETED
|
12
|
11
|
|
Randomization to First Dose
NOT COMPLETED
|
2
|
2
|
|
First Dose to End of Study
STARTED
|
12
|
11
|
|
First Dose to End of Study
COMPLETED
|
0
|
0
|
|
First Dose to End of Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
Trabedersen 10 µM
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Randomization to First Dose
Withdrawal by Subject
|
0
|
2
|
|
Randomization to First Dose
Sponsor decision
|
1
|
0
|
|
Randomization to First Dose
Other
|
1
|
0
|
|
First Dose to End of Study
End of trial
|
5
|
5
|
|
First Dose to End of Study
Progressive disease
|
5
|
3
|
|
First Dose to End of Study
Sponsor decision
|
1
|
2
|
|
First Dose to End of Study
Death
|
1
|
0
|
|
First Dose to End of Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
Baseline characteristics by cohort
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 11.63 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Native Alaskan
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
India
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Height (cm) (Descriptive analysis, only)
|
172.57 cm
STANDARD_DEVIATION 9.913 • n=5 Participants
|
170.29 cm
STANDARD_DEVIATION 10.019 • n=7 Participants
|
171.52 cm
STANDARD_DEVIATION 9.829 • n=5 Participants
|
|
Weight (kg) (Descriptive analysis, only)
|
75.34 kg
STANDARD_DEVIATION 17.265 • n=5 Participants
|
71.62 kg
STANDARD_DEVIATION 14.213 • n=7 Participants
|
73.62 kg
STANDARD_DEVIATION 15.731 • n=5 Participants
|
|
Diagnosis of Anaplastic Astrocytoma (AA) World Health Organization (WHO) Grade III
Refractory
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Diagnosis of Anaplastic Astrocytoma (AA) World Health Organization (WHO) Grade III
Recurrent
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Time of first diagnosis of AA WHO Grade III (years) (Descriptive analysis, only)
|
1.71 years
STANDARD_DEVIATION 1.110 • n=5 Participants
|
1.81 years
STANDARD_DEVIATION 1.194 • n=7 Participants
|
1.75 years
STANDARD_DEVIATION 1.124 • n=5 Participants
|
|
Diagnosis of other brain tumor prior to diagnosis of Anaplastic Astrocytoma WHO Grade III
AA WHO Grade I
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Diagnosis of other brain tumor prior to diagnosis of Anaplastic Astrocytoma WHO Grade III
AA WHO Grade II
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of other brain tumor prior to diagnosis of Anaplastic Astrocytoma WHO Grade III
Not diagnosed with Other Brain Tumor
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Diagnosis of other brain tumor prior to diagnosis of Anaplastic Astrocytoma WHO Grade III
Other diagnosis
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis of Secondary Glioblastoma Multiforme (GBM) (WHO Grade IV)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Time to first diagnosis of Secondary GBM (years) (Descriptive analysis, only)
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
0.03 years
STANDARD_DEVIATION NA • n=7 Participants
|
0.03 years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Previous diagnosis of Astrocytoma or AA before diagnosis of Secondary Glioblastoma Multiforme
Previous diagnosis of Astrocytoma
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Previous diagnosis of Astrocytoma or AA before diagnosis of Secondary Glioblastoma Multiforme
Previous diagnosis of Anaplastic Astrocytoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
One or more Prior Surgical Treatments
Yes
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
One or more Prior Surgical Treatments
No
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
One or more Prior Radiotherapy Regimens
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
One or more Prior Chemotherapy
Yes
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
One or more Prior Chemotherapy
No
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
One or more Prior Immunotherapy
Yes
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
One or more Prior Immunotherapy
No
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.
Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
|
28.6 percentage of participants
Interval 11.7 to 54.6
|
15.4 percentage of participants
Interval 4.3 to 42.2
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.
Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category "Lost to / insufficient follow-up" includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Survival at 24 Months in the Intent-to-treat Population - Number of Participants
Alive
|
4 participants
|
2 participants
|
|
Survival at 24 Months in the Intent-to-treat Population - Number of Participants
Died
|
7 participants
|
5 participants
|
|
Survival at 24 Months in the Intent-to-treat Population - Number of Participants
Lost to/insufficient follow-up
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12, 18, and 21 monthsPopulation: The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.
Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Survival rates at 12 months
|
57.1 percentage of participants
Interval 32.6 to 78.6
|
53.8 percentage of participants
Interval 29.1 to 76.8
|
|
Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Survival rates at 18 months
|
42.9 percentage of participants
Interval 21.4 to 67.4
|
38.5 percentage of participants
Interval 17.7 to 64.5
|
|
Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Survival rates at 21 months
|
35.7 percentage of participants
Interval 16.3 to 61.2
|
23.1 percentage of participants
Interval 8.2 to 50.3
|
SECONDARY outcome
Timeframe: 12, 18, and 21 monthsPopulation: The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.
Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category "Lost to follow-up" for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Alive at 12 months
|
8 participants
|
7 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Died at 12 months
|
5 participants
|
1 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 12 months
|
1 participants
|
5 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Alive at 18 months
|
6 participants
|
5 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Died at 18 months
|
7 participants
|
3 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 18 months
|
1 participants
|
5 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Alive at 21 months
|
5 participants
|
3 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Died at 21 months
|
7 participants
|
5 participants
|
|
Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 21 months
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.
Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)
|
458.0 days
Interval 193.0 to
The upper limit of the 95% confidence interval could not be calculated because of insufficient data.
|
584.5 days
Interval 426.0 to
The upper limit of the 95% confidence interval could not be calculated because of insufficient data.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Tumor response was classified based on the (neuro-)radiologist's evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below: * Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved. * Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved. * Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse. * Stable Disease (SD): all other situations. Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Partial Response (PR)
|
2 participants
|
1 participants
|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Stable Disease (SD)
|
2 participants
|
6 participants
|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Progressive Disease (PD)
|
7 participants
|
1 participants
|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Unknown
|
1 participants
|
3 participants
|
|
Response Category by Independent Review in the Intent-to-treat Population - Number of Participants
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
|
14.3 percentage of participants
Interval 4.0 to 39.9
|
7.7 percentage of participants
Interval 1.4 to 33.3
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
|
28.6 percentage of participants
Interval 11.7 to 54.6
|
53.8 percentage of participants
Interval 29.1 to 76.8
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate. Censoring rules were: * at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death. * at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression * at the date of death or last tumor assessment -- death or PD after one missed tumor assessment * at the date of last tumor assessment -- death or PD after more than one missed tumor assessment * at the date of last tumor assessment -- participants on ongoing treatment at data cut-off
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)
|
NA days
Due to early discontinuation of study, an insufficient number of patients reached this endpoint for estimation.
|
NA days
Due to early discontinuation of study, an insufficient number of patients reached this endpoint for estimation.
|
SECONDARY outcome
Timeframe: 10, 12, 14, 16, 18, 21, and 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Tumor response was classified based on the (neuro-)radiologist's evaluation: * Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved. * Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved. * Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse. * Stable Disease (SD): all other situations. Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of "Progressed" versus "Not Progressed". Participants who had MRI assessment results missing or unknown were "UNK or missing", and were treated as "Progressed" for the purposes of the calculation.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 21 months
|
1 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 21 months
|
6 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 10 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 10 months
|
3 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 10 months
|
4 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 10 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 12 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 12 months
|
2 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 12 months
|
5 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 12 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 14 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 14 months
|
2 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 14 months
|
5 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 14 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 16 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 16 months
|
2 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 16 months
|
5 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 16 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 18 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 18 months
|
2 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 18 months
|
5 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 18 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 21 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 21 months
|
0 participants
|
1 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Progressed at 24 months
|
7 participants
|
5 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Not progressed at 24 months
|
1 participants
|
0 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Status unknown / missing at 24 months
|
6 participants
|
7 participants
|
|
Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants
Lost to follow-up at 24 months
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10, 12, 14, 16, 18, 21 and 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Tumor response was classified based on the (neuro-)radiologist's evaluation: * Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved. * Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved. * Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse. * Stable Disease (SD): all other situations. Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of "Progressed" versus "Not Progressed". Participants who had MRI assessment results missing or unknown were "UNK or missing", and were treated as "Progressed" for the purposes of the calculation.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 10 months
|
78.6 percentage of participants
Interval 52.4 to 92.4
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 12 months
|
85.7 percentage of participants
Interval 60.1 to 96.0
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 14 months
|
85.7 percentage of participants
Interval 60.1 to 96.0
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 16 months
|
85.7 percentage of participants
Interval 60.1 to 96.0
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 18 months
|
85.7 percentage of participants
Interval 60.1 to 96.0
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 21 months
|
92.9 percentage of participants
Interval 68.5 to 98.7
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
|
Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)
Progression rate at 24 months
|
92.9 percentage of participants
Interval 68.5 to 98.7
|
100.0 percentage of participants
Interval 77.2 to 100.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The Intent-to-treat population includes all participants randomized.
Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.
Outcome measures
| Measure |
Trabedersen 10 µM
n=14 Participants
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=13 Participants
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)
|
57.0 days
Interval 57.0 to
The upper limit of the 95% confidence interval was not calculable because of insufficient data.
|
153.5 days
Interval 65.0 to 209.0
|
Adverse Events
Trabedersen 10 µM
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Chemotherapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabedersen 10 µM
n=13 participants at risk
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=11 participants at risk
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Nervous system disorders
Grand mal convulsion
|
15.4%
2/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Nervous system disorder
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Partial seizures
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Meningitis
|
15.4%
2/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
15.4%
2/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Haematemesis
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Device malfunction
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Device occlusion
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Surgical and medical procedures
Neurosurgery
|
7.7%
1/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
Other adverse events
| Measure |
Trabedersen 10 µM
n=13 participants at risk
10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
|
Chemotherapy
n=11 participants at risk
Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm.
|
|---|---|---|
|
Nervous system disorders
Headache
|
53.8%
7/13 • Number of events 7 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Partial seizures
|
30.8%
4/13 • Number of events 4 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Brain oedema
|
23.1%
3/13 • Number of events 3 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Hemiparesis
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Convulsion
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Epilepsy
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Facial palsy
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Grand mal convulsion
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Somnolence
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Speech disorder
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Acquired epileptic aphasia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Aphasia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Complex partial seizures
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Hyperaesthesia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Loss of consciousness
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Monoplegia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Nervous system disorder
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Paralysis
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Simple partial seizures
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Asthenia
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
27.3%
3/11 • Number of events 3 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Pyrexia
|
38.5%
5/13 • Number of events 5 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Chills
|
23.1%
3/13 • Number of events 3 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Device occlusion
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Gait disturbance
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Administration site reaction
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Device alarm issue
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Device malfunction
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Medical device pain
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Medical device site reaction
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
General disorders
Vessel puncture site haemorrhage
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Abdominal distention
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Gastrointestinal disorders
Haematemesis
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
36.4%
4/11 • Number of events 4 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
27.3%
3/11 • Number of events 3 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Neutrophil count
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
White blood cell count
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
18.2%
2/11 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
CSF protein increased
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Haemoglobin
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Pseudomonas test positive
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Staphylococcus test postivie
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
Weight increased
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Investigations
White blood cell count increased
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Meningitis
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Skin bacterial infection
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Psychiatric disorders
Confusional state
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Psychiatric disorders
Restlessness
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Injury, poisoning and procedural complications
Meningitis chemical
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Eye disorders
Blepharospasm
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Eye disorders
Hippus
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
15.4%
2/13 • Number of events 2 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Renal and urinary disorders
Urethral pain
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
9.1%
1/11 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Vascular disorders
Varicose veins
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Ear and labyrinth disorders
Ear discomfort
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
|
Surgical and medical procedures
Neurosurgery
|
7.7%
1/13 • Number of events 1 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
0.00%
0/11 • Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Only treatment-emergent adverse events are listed, defined as any AE whose onset occurred or intensity worsened after undertaking the first study procedure or first dose of study drug (whichever occurred first) but less than 28 days after medication/procedures had stopped. Adverse events (including lab tests) were assessed at study visits.
|
Additional Information
Medical Officer
Isarna Therapeutics GmbH, formerly Antisense Pharma GmbH
Phone: +49-89-890831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator and Sponsor both have publication / presentation privileges. Investigator abstracts or publications had to be reviewed and approved by the Sponsor prior to submission or presentation. The Clinic/Investigator agrees to delete information or defer publication or presentation, if (i) publication would hinder or delay the development of the investigational product or (ii) necessary to permit the filing of any desired patent applications by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER