Trial Outcomes & Findings for A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT03135262)
NCT ID: NCT03135262
Last Updated: 2021-12-07
Results Overview
It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. phases. The study was closed because at escalation doses 100 (in combination with venetoclax 400 mg) and 150 mg (in combination with venetoclax 200 mg) Idasanutlin, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The subpopulations of DLBCL and FL were showed no difference in their genetic subtype make-up, therefore, Cohorts Safety, 1, 2, 3 contain both populations. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3.
TERMINATED
PHASE1/PHASE2
29 participants
Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)
2021-12-07
Participant Flow
29 Participants (ITT population) were enrolled at 13 sites in the USA, Australia, South Korea, New Zealand and Germany during the dose escalation phase. 1 participant was undefined as the diagnosis at study entry was not provided. Due to the study's pre-mature termination, the planned Dose Expansion Phase did not take place for both arms DLBCL and FL.
The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase. In each DLBCL and FL arm, participants are in Safety Cohort, Cohort 1, Cohort 2, Cohort 3 and Cohort 3- Not defined (DLBCL only). All Adverse Events are reported per Cohort rather than per Arm.
Participant milestones
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 1
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 2
Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
7
|
6
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
7
|
6
|
1
|
Reasons for withdrawal
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 1
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 2
Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Overall Study
discontinued due to worsening of pre-existing medical condition
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progression of disease
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
6
|
2
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
2
|
4
|
4
|
3
|
0
|
Baseline Characteristics
ITT
Baseline characteristics by cohort
| Measure |
Dose-Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose-Escalation DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 15.5 • n=5 Participants • ITT
|
68.5 Years
STANDARD_DEVIATION 8.7 • n=7 Participants • ITT
|
72.4 Years
STANDARD_DEVIATION 8.6 • n=5 Participants • ITT
|
74.3 Years
STANDARD_DEVIATION 5.5 • n=4 Participants • ITT
|
25.0 Years
STANDARD_DEVIATION 0 • n=21 Participants • ITT
|
66.1 Years
STANDARD_DEVIATION 14.4 • n=10 Participants • ITT
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • ITT Population
|
3 Participants
n=7 Participants • ITT Population
|
3 Participants
n=5 Participants • ITT Population
|
3 Participants
n=4 Participants • ITT Population
|
0 Participants
n=21 Participants • ITT Population
|
12 Participants
n=10 Participants • ITT Population
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • ITT Population
|
3 Participants
n=7 Participants • ITT Population
|
4 Participants
n=5 Participants • ITT Population
|
3 Participants
n=4 Participants • ITT Population
|
1 Participants
n=21 Participants • ITT Population
|
17 Participants
n=10 Participants • ITT Population
|
|
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
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
29 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)Population: Safety Population
It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. phases. The study was closed because at escalation doses 100 (in combination with venetoclax 400 mg) and 150 mg (in combination with venetoclax 200 mg) Idasanutlin, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The subpopulations of DLBCL and FL were showed no difference in their genetic subtype make-up, therefore, Cohorts Safety, 1, 2, 3 contain both populations. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab
|
NA mg
No qualifying value data available
|
NA mg
No qualifying value data available
|
150 mg
|
NA mg
No qualifying value data available
|
NA mg
No qualifying value data available
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)Population: Safety Population
It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. The study was closed because at escalation doses 200 (in combination with 150 mg idasanutlin) and 400 (in combination with 100 mg idasanutlin) mg Venetoclax, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The safety cohort had a different venetoclax schedule of 5 days to ensure safety. Remaining cohorts used a 10 days schedule. No RP2D was identified in the Cohorts 1 and 3.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab
|
NA mg
No qualifying value data available
|
NA mg
No qualifying value data available
|
200 mg
|
NA mg
No qualifying value data available
|
NA mg
No qualifying value data available
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)Population: Safety-Evaluable Patients
DLT is defined as any one of the following events occurring during first two Cycles of treatment and assessed by the investigator as clearly not related to patient's underlying disease: - Any Grade 5 adverse event (AE) unless unequivocally due to the underlying malignancy or extraneous causes; - AE of any grade that leads to a delay of more than 14 days at the start of next treatment cycle; - Hematologic AEs (neutropenia, thrombocytopenia); - Non-hematologic AE, except IRRs, laboratory TLS without manifestations of clinical TLS, AST or ALT, diarrhea, nausea or vomiting, fatigue, asthenia, anorexia, or constipation, hepatic transaminase.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
28.6 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Baseline up to approximately 48 monthsPopulation: Safety Population
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a casual relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: At end of Induction (EOI) (within 6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days])Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). Therefore the result data not derived and not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: ITT Population; exploratory analysis of the dose escalation phase (Part I). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Part II), but it was not opened (i.e., no enrollment) and at the study was terminated early.
The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based complete response (CR), which required a complete metabolic response with a score of 1, 2 or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[\<=\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and \<= liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if intermediate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Percentage of Participants With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
|
22.2 Percentage of Participants
Interval 4.1 to 54.96
|
16.7 Percentage of Participants
Interval 0.85 to 58.18
|
28.6 Percentage of Participants
Interval 5.34 to 65.87
|
16.7 Percentage of Participants
Interval 0.85 to 58.18
|
0 Percentage of Participants
Interval 0.0 to 95.0
|
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e. , no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required to complete radiologic response with all of the following: target nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. Therefore the result data not derived and not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: ITT Population; exploratory analysis of the dose escalation phase (Part I). The study plan was for efficacy analyses to be based on responses in participants enrolled during expansion phase (Part II), but it was not opened (i.e., no enrollment) and at the study was terminated early.
The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who received at least 2 cycles of Induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. This outcome measure therefore not derived and not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The IRC was to evaluate responses at the end of induction treatment using Luagno 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2 or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Therefore the result data not derived and not reported. The study was pre-maturely terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: ITT Population
The investigator was to evaluate responses at end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.
Outcome measures
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 1
n=6 Participants
Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escaltion DLBCL and FL Cohort 2
n=7 Participants
Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 Participants
Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 Participants
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
|
33.3 Percentage of Participants
Interval 9.77 to 65.51
|
16.7 Percentage of Participants
Interval 0.85 to 58.18
|
28.6 Percentage of Participants
Interval 5.34 to 65.87
|
33.3 Percentage of Participants
Interval 6.28 to 72.87
|
0 Percentage of Participants
Interval 0.0 to 95.0
|
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a \>=50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/nomal, regressed, but no increase; and spleen must have regressed by \>50% in length. Therefore the result data not derived and not reported. The study was pre-maturely terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a \>=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. The study was pre-maturely terminated at escalation phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 monthsPopulation: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II)., but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I).
The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a \>=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. The study was pre-maturely terminated at escalation phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Serum Concentration of Obinutuzumab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6 (each cycle = 28 days)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Serum Concentration of Obinutuzumab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4, 6; 30 min post-dose on Day 1 of Cycles 1 and 6 (each cycle = 28 days)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Serum Concentration of Rituximab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Serum Concentration of Rituximab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Plasma Concentration of Idasanutlin in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Plasma Concentration of Idasanutlin in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Plasma Concentration of Venetoclax in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)Population: ITT Population was planned. Due to the pre-mature study termination, no participants were available for this endpoint and result data were not collected.
Observed Plasma Concentration of Venetoclax in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated.
Outcome measures
Outcome data not reported
Adverse Events
Dose Escalation DLBCL and FL Safety Cohort
Dose Escalation DLBCL and FL Cohort 1
Dose Escalation DLBCL and FL Cohort 2
Dose Escalation DLBCL and FL Cohort 3
Not Defined for DLBCL or FL Subgroups Cohort 3
Serious adverse events
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 participants at risk
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 1
n=6 participants at risk
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 2
n=7 participants at risk
Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 participants at risk
Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 participants at risk
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
General disorders
PYREXIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
11.1%
1/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
HEADACHE
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
Other adverse events
| Measure |
Dose Escalation DLBCL and FL Safety Cohort
n=9 participants at risk
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 1
n=6 participants at risk
Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 2
n=7 participants at risk
Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
|
Dose Escalation DLBCL and FL Cohort 3
n=6 participants at risk
Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
|
Not Defined for DLBCL or FL Subgroups Cohort 3
n=1 participants at risk
Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
44.4%
4/9 • Number of events 5 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
57.1%
4/7 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
33.3%
3/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
42.9%
3/7 • Number of events 8 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
33.3%
2/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
77.8%
7/9 • Number of events 13 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
83.3%
5/6 • Number of events 8 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
100.0%
7/7 • Number of events 20 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
83.3%
5/6 • Number of events 21 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
77.8%
7/9 • Number of events 9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
66.7%
4/6 • Number of events 5 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
100.0%
7/7 • Number of events 13 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
83.3%
5/6 • Number of events 6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Eye disorders
EYE DISORDER
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Eye disorders
EYE PAIN
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Eye disorders
PHOTOPHOBIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Eye disorders
VISION BLURRED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
33.3%
3/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
ANAL INCONTINENCE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.2%
2/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
33.3%
2/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
DIARRHOEA
|
55.6%
5/9 • Number of events 9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
57.1%
4/7 • Number of events 6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
66.7%
4/6 • Number of events 10 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
FLATULENCE
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
33.3%
3/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
6/9 • Number of events 14 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
66.7%
4/6 • Number of events 6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
42.9%
3/7 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 8 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
STOMATITIS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
TONGUE HAEMATOMA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
3/9 • Number of events 5 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
33.3%
2/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
CHEST PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
CHILLS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
FATIGUE
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
50.0%
3/6 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
42.9%
3/7 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
11.1%
1/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
OEDEMA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
PAIN
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
PYREXIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
General disorders
UNEVALUABLE EVENT
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
INFECTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
MUCOSAL INFECTION
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
11.1%
1/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
SINUSITIS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
33.3%
3/9 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
33.3%
3/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
PRODUCT ADMINISTRATION ERROR
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
PRODUCT DOSE OMISSION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Injury, poisoning and procedural complications
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
ALANINE AMINOTRANSFERASE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
22.2%
2/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
11.1%
1/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
PLATELET COUNT DECREASED
|
11.1%
1/9 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
RESPIROVIRUS TEST POSITIVE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
SERUM FERRITIN INCREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
WEIGHT DECREASED
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
11.1%
1/9 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 5 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
33.3%
2/6 • Number of events 7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
28.6%
2/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
22.2%
2/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
1/9 • Number of events 3 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
28.6%
2/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
22.2%
2/9 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
DIZZINESS
|
22.2%
2/9 • Number of events 4 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
HEADACHE
|
33.3%
3/9 • Number of events 5 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
28.6%
2/7 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
NEURALGIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
PARAESTHESIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
RADICULAR PAIN
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Psychiatric disorders
ANXIETY
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Psychiatric disorders
INSOMNIA
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Renal and urinary disorders
DYSURIA
|
11.1%
1/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
22.2%
2/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT CONGESTION
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA AB IGNE
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
11.1%
1/9 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 2 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
FLUSHING
|
11.1%
1/9 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
LYMPHATIC FISTULA
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
14.3%
1/7 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.00%
0/9 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/6 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/7 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
16.7%
1/6 • Number of events 1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
0.00%
0/1 • From Baseline Up to Approximately 3 Years
Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
|
Additional Information
Reference Study ID Number: BH39147
www.roche.com/about_roche/roche_worldwide.htm
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER