Trial Outcomes & Findings for Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (NCT NCT05883449)
NCT ID: NCT05883449
Last Updated: 2025-08-20
Results Overview
Best ORR (complete response (CR) + partial response \[PR\]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.
Results posted on
2025-08-20
Participant Flow
The three experimental Arms/Groups: 'Dose Level A in Hodgin Lymphoma', 'Dose Level B in Hodgin Lymphoma' and 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL' were not enrolled due to the decision to terminate this study earlier, which was based solely on the financial situation of the company and was not related to the safety or efficacy.
Participant milestones
| Measure |
Safety run-in Cohort 1
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 4
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
3
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
Baseline characteristics by cohort
| Measure |
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Total
n=25 Participants
Total of all reporting groups
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 14.61 • n=206 Participants
|
46.0 years
STANDARD_DEVIATION 19.8 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 18.07 • n=31 Participants
|
50.5 years
STANDARD_DEVIATION 20.68 • n=99 Participants
|
43.6 years
STANDARD_DEVIATION 19.21 • n=107 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
25 participants
n=31 Participants
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
PRIMARY outcome
Timeframe: Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
Best ORR (complete response (CR) + partial response \[PR\]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) by Independent Radiology Committee
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)Population: All patients in the Safety Run In Set who had a response (CR or PR) assessed by the independent review committee.
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=5 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=5 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=5 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Duration of Response by Independent Radiology Committee
|
6.97 months
Interval 2.3 to
Not enough events to calculate the data
|
4.90 months
Interval 2.2 to
Not enough events to calculate the data
|
NA months
Not enough events to calculate the data
|
NA months
Not enough events to calculate the data
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Complete Response Rate (CRR) by Independent Radiology Committee
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification
|
6 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)Population: All patients in the Safety Run In Set who had a response (CR or PR) assessed by the investigator.
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=4 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=5 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Duration of Response by Investigator
|
4.65 months
Interval 2.3 to
Not enough events to calculate the data
|
3.86 months
Interval 2.2 to
Not enough events to calculate the data
|
6.28 months
Interval 2.1 to
Not enough events to calculate the data
|
NA months
Not enough events to calculate the data
|
SECONDARY outcome
Timeframe: Throughout study completion (up to 20 months)Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Incidence of Subjects Receiving Subsequent Transplant
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)Population: The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Frequency of Subjects With Study Drug Related TEAEs
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)Population: The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
The number of subjects who had serious treatment emergent adverse events.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Frequency of Subjects With Serious Treatment Emergent Adverse Events
|
5 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During treatment cycles (up to 6 months)Population: The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
The number of subjects developing anti-drug antibodies (ADAs) against AFM13
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first treatment received until the first progression disease assessed by IRC or death.Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) by Independent Radiology Committee
|
8.28 months
Interval 1.35 to
Not enough events to calculate the data.
|
4.17 months
Interval 1.45 to
Not enough events to calculate the data.
|
7.66 months
Interval 1.28 to
Not enough events to calculate the data.
|
NA months
Not enough events to calculate the data.
|
SECONDARY outcome
Timeframe: From the first treatment received until the death.Population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.
Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation.
Outcome measures
| Measure |
Safety run-in Cohort 4
n=6 Participants
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 1
n=6 Participants
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=6 Participants
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 Participants
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Overall Survival
|
NA months
Not enough events to calculate the data.
|
NA months
Not enough events to calculate the data.
|
12.25 months
Interval 3.48 to
Not enough events to calculate the data.
|
9.72 months
Not enough events to calculate the data. Due to high levels of participant censoring CI could not be calculated while median was able to be determined.
|
Adverse Events
Safety run-in Cohort 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Safety run-in Cohort 2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 4 deaths
Safety run-in Cohort 3
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Safety run-in Cohort 4
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety run-in Cohort 1
n=6 participants at risk
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 participants at risk
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 participants at risk
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 4
n=6 participants at risk
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Cytomegalovirus Oesophagitis
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Immune system disorders
Cytokine Release Syndrome
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
Other adverse events
| Measure |
Safety run-in Cohort 1
n=6 participants at risk
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 2
n=7 participants at risk
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 3
n=6 participants at risk
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
Safety run-in Cohort 4
n=6 participants at risk
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
AB-101: NK cell therapy, intravenous infusion
Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion
Fludarabine: Lymphodepleting chemotherapy, intravenous infusion
Interleukin-2: Immune cytokine, subcutaneously
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
85.7%
6/7 • Number of events 14 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
66.7%
4/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
66.7%
4/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
71.4%
5/7 • Number of events 8 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
50.0%
3/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 10 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
71.4%
5/7 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
50.0%
3/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
3/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Oral Pain
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Anal Fistula
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Anal Incontinence
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Oroantral Fistula
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Rectal Fissure
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
71.4%
5/7 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
66.7%
4/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Gastrointestinal disorders
Pyrexia
|
66.7%
4/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
71.4%
5/7 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
57.1%
4/7 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Injection Site Reaction
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Catheter Site Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Chest Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Facial Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Injection Site Induration
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Malaise
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
50.0%
3/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Rhinovirus Infection
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Covid-19
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Enterovirus Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Hcov-Oc43 Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
33.3%
2/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
57.1%
4/7 • Number of events 22 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
66.7%
4/6 • Number of events 10 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
42.9%
3/7 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
66.7%
4/6 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Brain Fog
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Extrapyramidal Disorder
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Muscle Spasticity
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Neuralgia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
3/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
4/6 • Number of events 12 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
3/6 • Number of events 6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
42.9%
3/7 • Number of events 12 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 3 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Platelet Count Decreased
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 5 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Anti-Hla Antibody Test
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Lipase Increased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Protein Total Decreased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Investigations
Weight Decreased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Psychiatric disorders
Confusional State
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Eye disorders
Scleral Hyperaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Eye disorders
Strabismus
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Immune system disorders
Cytokine Release Syndrome
|
16.7%
1/6 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
33.3%
2/6 • Number of events 4 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
28.6%
2/7 • Number of events 2 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
14.3%
1/7 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/7 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
0.00%
0/6 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
16.7%
1/6 • Number of events 1 • From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
- Publication restrictions are in place
Restriction type: OTHER