Trial Outcomes & Findings for Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05) (NCT NCT02658968)
NCT ID: NCT02658968
Last Updated: 2024-01-16
Results Overview
To determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as: * Haematologic toxicity: * Grade 4 neutropenia observed for greater than 7 days' duration * Grade 4 thrombocytopenia observed for greater than 7 days' duration * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration * Grade 3 or 4 thrombocytopenia with bleeding * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less * Grade 4 anaemia, unexplained by underlying disease * Non-haematologic toxicity: * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4 * Any other Grade 3 or 4 non-haematologic toxicities * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-01-16
Participant Flow
Participants were screened in the 28 days before receiving rituximab (42 days before receiving lilotomab and Betalutin). Participants were then allocated to one of four treatment cohorts following a "3+3" design. They received rituximab on Day -14, followed by Betalutin and lilotomab on Day 0. Two participants received rituximab but were withdrawn prior to receiving lilotomab and Betalutin and were therefore replaced.
Participant milestones
| Measure |
60/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/15
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/20
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
Rituximab Only
Received rituximab pre-treatment on Day -14. Did not receive Betalutin or lilotomab
|
|---|---|---|---|---|---|
|
Received Rituximab
STARTED
|
3
|
3
|
3
|
7
|
2
|
|
Received Rituximab
COMPLETED
|
3
|
3
|
3
|
7
|
0
|
|
Received Rituximab
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
|
Received Lilotomab and Betalutin
STARTED
|
3
|
3
|
3
|
7
|
0
|
|
Received Lilotomab and Betalutin
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
|
Received Lilotomab and Betalutin
NOT COMPLETED
|
3
|
3
|
3
|
6
|
0
|
Reasons for withdrawal
| Measure |
60/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/15
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/20
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
Rituximab Only
Received rituximab pre-treatment on Day -14. Did not receive Betalutin or lilotomab
|
|---|---|---|---|---|---|
|
Received Rituximab
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Received Rituximab
Progressive disease
|
0
|
0
|
0
|
0
|
1
|
|
Received Lilotomab and Betalutin
Disease progression (including death due to disease progression)
|
2
|
0
|
3
|
3
|
0
|
|
Received Lilotomab and Betalutin
Progressive disease
|
1
|
0
|
0
|
0
|
0
|
|
Received Lilotomab and Betalutin
Start of further anticancer therapy
|
0
|
2
|
0
|
2
|
0
|
|
Received Lilotomab and Betalutin
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Received Lilotomab and Betalutin
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)
Baseline characteristics by cohort
| Measure |
60/10
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/10
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/15
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
100/20
n=7 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.
|
Rituximab Only
n=2 Participants
Received rituximab pre-treatment on Day -14. Did not receive Betalutin or lilotomab
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 16.09 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
77.3 years
STANDARD_DEVIATION 76.0 • n=5 Participants
|
81.0 years
STANDARD_DEVIATION 7.07 • n=4 Participants
|
72 years
STANDARD_DEVIATION 7.07 • n=21 Participants
|
73.5 years
STANDARD_DEVIATION 12.85 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
ECOG score
Score 0
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
ECOG score
Score 1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
ECOG score
Score 2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as: * Haematologic toxicity: * Grade 4 neutropenia observed for greater than 7 days' duration * Grade 4 thrombocytopenia observed for greater than 7 days' duration * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration * Grade 3 or 4 thrombocytopenia with bleeding * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less * Grade 4 anaemia, unexplained by underlying disease * Non-haematologic toxicity: * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4 * Any other Grade 3 or 4 non-haematologic toxicities * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours
Outcome measures
| Measure |
60/10
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
|
100/10
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/15
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/20
n=7 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
|---|---|---|---|---|
|
Number of Participants With DLTs to Determine the MTD
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months - 2 yearsPopulation: Participants who had a baseline and at least one post-baseline computed tomography scan
Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification" (Cheson, 2014). The Cheson criteria, 2014 are a combined score taking into consideration, positive or negative scored PET scan, the contrast enhanced CT images and bone marrow biopsies when available.
Outcome measures
| Measure |
60/10
n=1 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
|
100/10
n=2 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/15
n=2 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/20
n=3 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
|---|---|---|---|---|
|
The Best Overall Tumour Response
Progressive disease
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
The Best Overall Tumour Response
No response/stable disease
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Best Overall Tumour Response
Complete response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Participants having dosimetry evaluation and having the schedule of whole body imaging or SPECT/CT scans
Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.
Outcome measures
| Measure |
60/10
n=1 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
|
100/10
n=1 Participants
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/15
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
100/20
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
|
|---|---|---|---|---|
|
Dosimetry
Liver
|
1.33 Gray
|
0.46 Gray
|
—
|
—
|
|
Dosimetry
Spleen
|
1.39 Gray
|
2.63 Gray
|
—
|
—
|
|
Dosimetry
Kidneys
|
0.70 Gray
|
0.73 Gray
|
—
|
—
|
|
Dosimetry
Image-based Red Marrow
|
0.52 Gray
|
0.38 Gray
|
—
|
—
|
|
Dosimetry
Total Body
|
0.07 Gray
|
1.16 Gray
|
—
|
—
|
Adverse Events
60/10
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
100/10
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
100/15
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
100/20
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Rituximab
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
60/10
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 .
|
100/10
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2.
|
100/15
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 .
|
100/20
n=7 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0.
|
Rituximab
n=18 participants at risk
Rituximab pre-treatment on Day -14
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Neutropenic sepsis
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Intestinal obstruction
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Disease progression
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
11.1%
2/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
Other adverse events
| Measure |
60/10
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 .
|
100/10
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2.
|
100/15
n=3 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 .
|
100/20
n=7 participants at risk
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0.
|
Rituximab
n=18 participants at risk
Rituximab pre-treatment on Day -14
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
66.7%
2/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Fatigue
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Asthenia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
11.1%
2/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Extravasation
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Oedema
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Blood calcium increased
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Gamma glutamyltransferase increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
11.1%
2/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
28.6%
2/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
11.1%
2/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
14.3%
1/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
33.3%
1/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
11.1%
2/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Malaise
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Chills
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Vascular disorders
Vascular compression
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonea
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/3 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
0.00%
0/7 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
|
5.6%
1/18 • All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years
Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60