Trial Outcomes & Findings for A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors (NCT NCT04424641)
NCT ID: NCT04424641
Last Updated: 2023-07-25
Results Overview
The DLT was defined as Grade (G) \>= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for \>1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
From Day 1 to Day 21 of first cycle
Results posted on
2023-07-25
Participant Flow
A total of 48 participants signed the informed consent form of whom 37 received study drug. The Safety Committee decided to stop enrollment during the dose-escalation part and therefore the expansion part of trial never started. Consequently, results are available for only the dose-escalation part.
Participant milestones
| Measure |
GEN1044 Doses 0.3/3/3 mg
Participants with locally advanced or metastatic non-central nervous system (CNS) solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on Cycle \[C\] 1 Day (D\] 1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by every 3 weeks (Q3W) until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
7
|
7
|
6
|
2
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
7
|
7
|
6
|
2
|
4
|
6
|
Reasons for withdrawal
| Measure |
GEN1044 Doses 0.3/3/3 mg
Participants with locally advanced or metastatic non-central nervous system (CNS) solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on Cycle \[C\] 1 Day (D\] 1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by every 3 weeks (Q3W) until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
3
|
0
|
3
|
0
|
1
|
2
|
|
Overall Study
Sponsor decision
|
0
|
2
|
3
|
7
|
2
|
2
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
Baseline characteristics by cohort
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 12.89 • n=7 Participants
|
60.4 Years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
59.3 Years
STANDARD_DEVIATION 8.18 • n=4 Participants
|
62.3 Years
STANDARD_DEVIATION 5.79 • n=21 Participants
|
52.0 Years
STANDARD_DEVIATION 8.49 • n=8 Participants
|
55.8 Years
STANDARD_DEVIATION 15.71 • n=8 Participants
|
54.2 Years
STANDARD_DEVIATION 15.29 • n=24 Participants
|
58.4 Years
STANDARD_DEVIATION 10.85 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
26 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 21 of first cyclePopulation: Dose-determining set (DDS) included all participants who received at least 1 dose of study drug during the dose-escalation part, and who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 21 days of dosing.
The DLT was defined as Grade (G) \>= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for \>1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.
Outcome measures
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=3 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=3 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 263 (corresponding to maximum observed duration)Population: Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically significant'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received.
Outcome measures
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAE
|
1 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TESAE
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 263 (corresponding to maximum observed duration)Population: Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.
Number of participants with laboratory values of Grade \>= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here. This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table. In case a participant reported multiple severity grades for a laboratory value, only the maximum grade was used.
Outcome measures
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Values
Lymphocyte count decreased
|
1 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Lipase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Serum amylase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Anemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Hypokalemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Hypomagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Hypoalbuminemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Gamma-glutamyl transferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Values
Hypermagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 233Population: Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.
The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response (CR) or Partial Response (PR)
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complete Response (CR) or Partial Response (PR)
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 263 (predose on Day 1 of Cycles 1, 2, 3, 5, 7, and then on Day 1 of every 4 cycles thereafter, end of treatment [EOT], and 30 days after last study drug)Population: Immunogenicity analysis set included all participants who received at least 1 dose of study drug and had evaluable immunogenicity samples.
The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.
Outcome measures
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=3 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=4 Participants
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
GEN1044 Doses 0.3/3/3 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
GEN1044 Doses 1/3/10 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
GEN1044 Doses 1/3/30 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
GEN1044 Doses 1/5/30 mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
GEN1044 Doses 1/10/30 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
GEN1044 Doses 1/5/37.5 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
GEN1044 Doses 1/5/45 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
GEN1044 Doses 1/3/60 mg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Fatigue
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 10 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
42.9%
3/7 • Number of events 13 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 9 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 9 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 9 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Associated Fever
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
Other adverse events
| Measure |
GEN1044 Doses 0.3/3/3 mg
n=1 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/10 mg
n=4 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/30 mg
n=7 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/30 mg
n=7 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/10/30 mg
n=6 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/37.5 mg
n=2 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/5/45 mg
n=4 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
GEN1044 Doses 1/3/60 mg
n=6 participants at risk
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
100.0%
4/4 • Number of events 7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
85.7%
6/7 • Number of events 23 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
57.1%
4/7 • Number of events 15 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
83.3%
5/6 • Number of events 13 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
100.0%
4/4 • Number of events 15 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 12 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
75.0%
3/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
71.4%
5/7 • Number of events 9 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
57.1%
4/7 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
75.0%
3/4 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
83.3%
5/6 • Number of events 10 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
75.0%
3/4 • Number of events 8 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
71.4%
5/7 • Number of events 10 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
83.3%
5/6 • Number of events 11 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
100.0%
4/4 • Number of events 8 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 8 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Asthenia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Chills
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Fatigue
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
100.0%
4/4 • Number of events 7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
57.1%
4/7 • Number of events 8 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Malaise
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
General disorders
Ulcer
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Immune system disorders
Cytokine Release Syndrome
|
100.0%
1/1 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
75.0%
3/4 • Number of events 10 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
42.9%
3/7 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
3/6 • Number of events 14 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
100.0%
2/2 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
66.7%
4/6 • Number of events 14 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Amylase Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
C-reactive Protein Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Lipase Increased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Investigations
Weight Decreased
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
83.3%
5/6 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
1/2 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
50.0%
2/4 • Number of events 6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 5 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar Erythrodysaesthesia Syndrome
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
75.0%
3/4 • Number of events 4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
33.3%
2/6 • Number of events 3 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Vascular disorders
Hot Flush
|
100.0%
1/1 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/7 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/6 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/2 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
0.00%
0/4 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
16.7%
1/6 • Number of events 1 • For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER