Trial Outcomes & Findings for First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (NCT NCT04358458)
NCT ID: NCT04358458
Last Updated: 2024-10-24
Results Overview
DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
During the first treatment cycle (Cycle length=28 days)
Results posted on
2024-10-24
Participant Flow
The study was conducted at investigative sites in Belgium, Denmark, France, Spain and the United States from 13 March 2020 to 28 July 2023.
This study was to be conducted in 2 parts; Part 1 was the dose-escalation phase and Part 2 was the expansion phase. However, the trial was terminated due to strategic evaluation of GEN3009 within context of Genmab's portfolio, the sponsor decided not to conduct the expansion phase (Part 2).
Participant milestones
| Measure |
Part 1: GEN3009 Dose Level A in Schedule 1 (S1)
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at Cycle 1 Day 1 (C1D1) and the remaining amount at Day 2 (C1D2).
|
Part 1: GEN3009 Dose Level D in Schedule (S2)
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
7
|
10
|
3
|
10
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
7
|
10
|
3
|
10
|
3
|
6
|
Reasons for withdrawal
| Measure |
Part 1: GEN3009 Dose Level A in Schedule 1 (S1)
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at Cycle 1 Day 1 (C1D1) and the remaining amount at Day 2 (C1D2).
|
Part 1: GEN3009 Dose Level D in Schedule (S2)
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
3
|
8
|
1
|
6
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Site is closing study participation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor request
|
2
|
3
|
3
|
0
|
2
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
Baseline Characteristics
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Baseline characteristics by cohort
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 3.46 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 8.81 • n=107 Participants
|
74.6 years
STANDARD_DEVIATION 8.68 • n=206 Participants
|
67.1 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 16.86 • n=31 Participants
|
69.4 years
STANDARD_DEVIATION 10.23 • n=30 Participants
|
70.3 years
STANDARD_DEVIATION 9.87 • n=3 Participants
|
60.8 years
STANDARD_DEVIATION 17.38 • n=6 Participants
|
66.7 years
STANDARD_DEVIATION 11.74 • n=114 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
35 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
25 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
38 Participants
n=114 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: During the first treatment cycle (Cycle length=28 days)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as an AE that meets one of the following criteria: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is 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. TEAEs are defined as AEs which begin, or worsen, during the on-treatment period ending 4 weeks after the last dose of study medication.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
3 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
AESIs are defined as events (serious or non-serious) that are of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs of Special Interest (AESI)
|
1 Participants
|
1 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
Laboratory parameters included hematology, serum chemistries and urinalysis. Clinically significant laboratory abnormalities were based upon the Investigator's discretion. Laboratory parameters captured as AEs are reported in this outcome measure.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Blood creatinine increased
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Blood alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Blood lactate dehydrogenase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs
Blood creatine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose up to end of treatment (up to 14.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Criteria for clinically notable (elevated and below normal values respectively) vital signs are as follows: Systolic Blood Pressure (SBP): ≥180 millimeters of mercury (mmHg) and an increase ≥20 mmHg from baseline, ≤90 mmHg and a decrease ≥20 mmHg from baseline; Diastolic Blood Pressure (DBP): ≥105 mmHg and an increase ≥15 mmHg from baseline, ≤50 mmHg and a decrease ≥15 mmHg from baseline; Heart rate: ≥120 beats per minute (bpm) with an increase of ≥15 bpm from baseline, ≤50 bpm and a decrease ≥15 bpm from baseline; Temperature: \> 38 degree Celsius (°C) and \< 35°C. Number of participants with clinically notable elevated and below normal vital signs values up to end of treatment are reported.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=5 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=9 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=8 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=2 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=5 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Notable Vital Signs
SBP: Below Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
DBP: Elevated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
DBP: Below Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
Heart Rate: Elevated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
Heart Rate: Below Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
Temperature: Elevated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
Temperature: Below Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Notable Vital Signs
SBP: Elevated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
Number of participants with dose delays and dose Interruptions due to AE, Coronavirus disease 2019 (COVID-19), drug administration issues and other unspecified reasons are reported.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose delay due to AE
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose delay due to Coronavirus disease 2019 (COVID-19)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose delay due to un-specified reason
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose interruption due to AE
|
0 Participants
|
1 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose interruption due to drug administration issues
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Delays and Dose Interruptions
Dose interruption due to unspecified reason
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.
Actual dose intensity (milligrams per cycle \[mg/cycle\]) is calculated as cumulative dose/number of cycles initiated.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Actual Dose Intensity
Cycles 1-3
|
114.67 mg/cycle
Standard Deviation 112.10
|
720.00 mg/cycle
Standard Deviation 0.00
|
1389.46 mg/cycle
Standard Deviation 278.91
|
2501.53 mg/cycle
Standard Deviation 992.91
|
2515.85 mg/cycle
Standard Deviation 1053.90
|
3903.62 mg/cycle
Standard Deviation 1135.72
|
5957.23 mg/cycle
Standard Deviation 766.90
|
6973.78 mg/cycle
Standard Deviation 1072.58
|
|
Actual Dose Intensity
Cycles 4-9
|
—
|
363.71 mg/cycle
Standard Deviation NA
Since there is only 1 participant, standard deviation (SD) was not estimable.
|
799.71 mg/cycle
Standard Deviation 10.64
|
1527.27 mg/cycle
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
—
|
2400.00 mg/cycle
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
2953.02 mg/cycle
Standard Deviation 349.28
|
—
|
|
Actual Dose Intensity
Cycle 10-until end of study
|
—
|
—
|
318.94 mg/cycle
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The pharmacokinetic analysis set (PAS) includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance (CL) of GEN3009
Cycle 1
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the lower limit of quantification (LLOQ).
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
|
Apparent Total Plasma Clearance (CL) of GEN3009
Cycle 2
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA Liters per day
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution of GEN3009
Cycle 1
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
|
Volume of Distribution of GEN3009
Cycle 2
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2 and 4 (S2 only); 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at a specified cycle.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=3 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=2 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=1 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=2 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=3 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009
Cycle 1
|
—
|
—
|
159.2796 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 95.7330
|
181.5966 micrograms*day per milliliter(ug*day/mL)
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
260.8704 micrograms*day per milliliter(ug*day/mL)
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
219.1863 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 46.3749
|
353.5017 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 177.2169
|
389.0321 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 126.8407
|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009
Cycle 2
|
—
|
—
|
132.6580 micrograms*day per milliliter(ug*day/mL)
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
159.3302 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 22.1333
|
—
|
159.3456 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 98.0641
|
363.4413 micrograms*day per milliliter(ug*day/mL)
Standard Deviation 190.0120
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at a specified cycle.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=2 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=8 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=8 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=5 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
AUC From Time 0 to Infinity (AUCinf) of GEN3009
Cycle 1
|
6.0154 ug*day/mL
Standard Deviation 3.8503
|
56.3289 ug*day/mL
Standard Deviation 22.4400
|
136.8615 ug*day/mL
Standard Deviation 72.7498
|
163.9206 ug*day/mL
Standard Deviation 52.0135
|
332.1408 ug*day/mL
Standard Deviation 73.1435
|
192.0412 ug*day/mL
Standard Deviation 90.3476
|
358.0010 ug*day/mL
Standard Deviation 183.3857
|
335.8745 ug*day/mL
Standard Deviation 117.1831
|
|
AUC From Time 0 to Infinity (AUCinf) of GEN3009
Cycle 2
|
5.9939 ug*day/mL
Standard Deviation 0.6498
|
46.4191 ug*day/mL
Standard Deviation 9.8966
|
139.9286 ug*day/mL
Standard Deviation 61.7235
|
127.4566 ug*day/mL
Standard Deviation 49.8017
|
957.4149 ug*day/mL
Standard Deviation 1427.7939
|
159.8668 ug*day/mL
Standard Deviation 73.6559
|
363.7766 ug*day/mL
Standard Deviation 190.3613
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
AUC From Time 0 to Time of Last Dose (AUClast) of GEN3009
Cycle 1
|
4.5524 ug*day/mL
Standard Deviation 2.3467
|
51.0701 ug*day/mL
Standard Deviation 17.1901
|
103.4129 ug*day/mL
Standard Deviation 73.3627
|
148.4079 ug*day/mL
Standard Deviation 41.7750
|
467.9622 ug*day/mL
Standard Deviation 283.7778
|
150.7393 ug*day/mL
Standard Deviation 96.0893
|
353.5017 ug*day/mL
Standard Deviation 177.2169
|
327.1762 ug*day/mL
Standard Deviation 109.9472
|
|
AUC From Time 0 to Time of Last Dose (AUClast) of GEN3009
Cycle 2
|
4.4707 ug*day/mL
Standard Deviation 1.3098
|
45.0924 ug*day/mL
Standard Deviation 9.1404
|
121.5349 ug*day/mL
Standard Deviation 53.0658
|
103.5413 ug*day/mL
Standard Deviation 61.7884
|
441.7798 ug*day/mL
Standard Deviation 542.0539
|
152.4631 ug*day/mL
Standard Deviation 74.1040
|
363.4413 ug*day/mL
Standard Deviation 190.0120
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GEN3009
Cycle 1
|
8.3000 microgram per milliliter (ug/mL)
Standard Deviation 3.5355
|
43.4000 microgram per milliliter (ug/mL)
Standard Deviation 12.7674
|
89.8714 microgram per milliliter (ug/mL)
Standard Deviation 39.8257
|
139.0000 microgram per milliliter (ug/mL)
Standard Deviation 43.8341
|
363.0667 microgram per milliliter (ug/mL)
Standard Deviation 460.6843
|
144.4778 microgram per milliliter (ug/mL)
Standard Deviation 79.0905
|
317.3333 microgram per milliliter (ug/mL)
Standard Deviation 51.4328
|
352.6667 microgram per milliliter (ug/mL)
Standard Deviation 58.5514
|
|
Maximum Observed Plasma Concentration (Cmax) of GEN3009
Cycle 2
|
8.1050 microgram per milliliter (ug/mL)
Standard Deviation 3.6699
|
46.1667 microgram per milliliter (ug/mL)
Standard Deviation 2.7934
|
118.4800 microgram per milliliter (ug/mL)
Standard Deviation 29.9458
|
147.4000 microgram per milliliter (ug/mL)
Standard Deviation 52.7286
|
572.0000 microgram per milliliter (ug/mL)
Standard Deviation 708.4659
|
237.0000 microgram per milliliter (ug/mL)
Standard Deviation 30.8869
|
394.6667 microgram per milliliter (ug/mL)
Standard Deviation 109.5871
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of GEN3009
Cycle 1
|
0.0765 days
Standard Deviation 0.0120
|
0.1490 days
Standard Deviation 0.0957
|
0.2084 days
Standard Deviation 0.0553
|
0.6039 days
Standard Deviation 0.6768
|
1.2123 days
Standard Deviation 1.5987
|
0.5030 days
Standard Deviation 0.2908
|
1.3817 days
Standard Deviation 0.0890
|
1.2580 days
Standard Deviation 0.0771
|
|
Time to Reach Cmax (Tmax) of GEN3009
Cycle 2
|
0.0445 days
Standard Deviation 0.0007
|
0.1650 days
Standard Deviation 0.1643
|
0.1656 days
Standard Deviation 0.0820
|
0.2740 days
Standard Deviation 0.3010
|
0.2030 days
Standard Deviation 0.0346
|
0.1620 days
Standard Deviation 0.0595
|
0.1983 days
Standard Deviation 0.0535
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Trough Concentrations (Ctrough) of GEN3009
Cycle 1
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
|
Trough Concentrations (Ctrough) of GEN3009
Cycle 2
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA ug/mL
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
SECONDARY outcome
Timeframe: Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)Population: The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t 1/2) of GEN3009
Cycle 2
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
|
Terminal Elimination Half-Life (t 1/2) of GEN3009
Cycle 1
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
NA days
Standard Deviation NA
Data was not estimable because the values were below the LLOQ.
|
SECONDARY outcome
Timeframe: From first dose until 30 days after the last dose (up to 15.5 months)Population: The immunogenicity analysis set included all participants who had received at least 1 dose of study drug and had a baseline and at least 1 evaluable on-treatment ADA sample.
Venous blood samples will be collected for measurement of serum concentrations of ADAs. Number of participants with positive ADAs are reported in this outcome measure. The detection of ADAs was performed using validated, specific and sensitive Electrochemiluminescence Immunoassay (ECLIA) method.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=3 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=8 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=9 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=3 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)Population: The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Overall number of participants Analyzed' signified the participants who achieved CR or PR.
DoR is defined as the time from the first documentation of objective tumor response \[Complete response (CR) or Partial response (PR)\] to the date of first disease progression (PD) or death as assessed by the investigator based on Lugano criteria for B-cell non-Hodgkin lymphoma (B-cell NHL) and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for chronic lymphocytic leukemia (CLL). Detailed definition of CR, PR and PD as per Lugano and iwCLL criteria in the protocol appendices.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=3 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=1 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=3 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=2 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=1 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
—
|
—
|
15.9 months
Interval 2.9 to
Upper limit of confidence interval (CI) not reached due to less number of participants with events.
|
—
|
NA months
Median, upper and lower limit of CI not reached due to less number of participants with events.
|
1.4 months
Interval 1.4 to
Upper limit of confidence interval CI not reached due to less number of participants with events.
|
NA months
Median, upper and lower limit of CI not reached due to less number of participants with events.
|
4.1 months
Upper and lower limit of CI not reached due to less number of participants with events.
|
SECONDARY outcome
Timeframe: From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)Population: The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Overall number of participants analyzed' indicates the number of participants who achieved CR or PR.
TTR: time from first dose of administration until date of first response as assessed by investigator based on Lugano criteria for B-cell NHL and iwCLL for CLL. It is derived for all participants who achieved PR or CR. Detailed definitions of CR, PR and PD as per Lugano and iwCLL criteria in the protocol appendices.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=3 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=1 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=3 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=2 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=1 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR)
|
—
|
—
|
1.3361 months
Standard Deviation 0.1004
|
—
|
1.8727 months
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
1.2704 months
Standard Deviation 0.2138
|
2.0370 months
Standard Deviation 1.0222
|
1.1828 months
Standard Deviation NA
Since there is only 1 participant, SD was not estimable.
|
SECONDARY outcome
Timeframe: From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)Population: The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.
PFS is defined as the time in days from Day 1 of Cycle 1 to the day of first documented PD, or the day of death due to any cause, whichever comes first as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. PFS was estimated using the Kaplan-Meier method. Detailed definitions of PD as per Lugano and iwCLL criteria in the protocol appendices.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.4 months
Interval 1.2 to
Upper limit of CI not reached due to less number of participants with events.
|
2.6 months
Interval 1.3 to
Upper limit of CI not reached due to less number of participants with events.
|
4.3 months
Interval 1.8 to
Upper limit of CI not reached due to less number of participants with events.
|
1.2 months
Interval 1.0 to 4.0
|
2.3 months
Interval 1.4 to
Upper limit of CI not reached due to less number of participants with events.
|
1.9 months
Interval 0.2 to 3.4
|
NA months
Interval 1.3 to
Median and upper limit of CI not reached due to less number of participants with events.
|
0.8 months
Interval 0.4 to
Upper limit of CI not reached due to less number of participants with events.
|
SECONDARY outcome
Timeframe: From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)Population: The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 19.1 to
Upper limit of CI not reached due to less number of participants with events.
|
NA months
Interval 5.2 to
Median and upper and limit of CI not reached due to less number of participants with events.
|
NA months
Interval 1.8 to
Median and upper and limit of CI not reached due to less number of participants with events.
|
10.9 months
Interval 0.8 to 18.0
|
NA months
Interval 14.0 to
Upper limit of CI not reached due to less number of participants with events.
|
13.7 months
Interval 0.2 to
Upper limit of CI not reached due to less number of participants with events.
|
13.1 months
Interval 7.0 to
Upper limit of CI not reached due to less number of participants with events.
|
6.6 months
Interval 0.5 to
Upper limit of CI not reached due to less number of participants with events.
|
SECONDARY outcome
Timeframe: From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)Population: The Response Evaluable Set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment.
ORR: the percentage of participants who achieved a best overall response (BOR) of CR or PR as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. Detailed definitions of CR and PR as per Lugano and iwCLL criteria in the protocol appendices.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=3 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=8 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=8 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
0 percentage of participants
Interval 0.0 to 36.9
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)Population: The Response Evaluable set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment.
CR rate was estimated using Clopper-Pearson method. Detailed definitions of CR as per Lugano and iwCLL criteria in the protocol appendices.
Outcome measures
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 Participants
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=3 Participants
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 Participants
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=8 Participants
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 Participants
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=8 Participants
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 Participants
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 Participants
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
CR Rate
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
0 percentage of participants
Interval 0.0 to 36.9
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 36.9
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 45.9
|
Adverse Events
Part 1: GEN3009 Dose Level A in S1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: GEN3009 Dose Level B in S1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 1: GEN3009 Dose Level C in S1
Serious events: 4 serious events
Other events: 7 other events
Deaths: 3 deaths
Part 1: GEN3009 Dose Level D in S1
Serious events: 7 serious events
Other events: 9 other events
Deaths: 8 deaths
Part 1: GEN3009 Dose Level D in S2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: GEN3009 Dose Level E in S1
Serious events: 4 serious events
Other events: 10 other events
Deaths: 6 deaths
Part 1: GEN3009 Dose Level F in S1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 1: GEN3009 Dose Level G in S1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 participants at risk
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 participants at risk
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 participants at risk
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 participants at risk
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 participants at risk
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 participants at risk
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 8 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 participants at risk
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 participants at risk
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
30.0%
3/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
Other adverse events
| Measure |
Part 1: GEN3009 Dose Level A in S1
n=3 participants at risk
Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level B in S1
n=4 participants at risk
Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level C in S1
n=7 participants at risk
Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
|
Part 1: GEN3009 Dose Level D in S1
n=10 participants at risk
Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level D in S2
n=3 participants at risk
Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
|
Part 1: GEN3009 Dose Level E in S1
n=10 participants at risk
Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 8 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level F in S1
n=3 participants at risk
Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
Part 1: GEN3009 Dose Level G in S1
n=6 participants at risk
Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
4/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Refractive amblyopia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
50.0%
2/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Malaise
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Injection site phlebitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
30.0%
3/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
30.0%
3/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Oedema
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
4/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
7/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
90.0%
9/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
3/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
70.0%
7/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
3/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
6/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
42.9%
3/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
40.0%
4/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Chills
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Feeling jittery
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Vein disorder
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
50.0%
2/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
42.9%
3/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
30.0%
3/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
7/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
70.0%
7/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
3/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
100.0%
10/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
66.7%
4/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
20.0%
2/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
50.0%
2/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
30.0%
3/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
40.0%
4/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
2/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
25.0%
1/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
28.6%
2/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
General disorders
Infusion site paraesthesia
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
75.0%
3/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
42.9%
3/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
60.0%
6/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
60.0%
6/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
10.0%
1/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
16.7%
1/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/4 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
14.3%
1/7 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/10 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
33.3%
1/3 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
0.00%
0/6 • Deaths were assessed up to approximately 3 years, 4 months; Adverse Events were assessed up to 15.5 months
The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60