Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy (NCT NCT05435339)

NCT ID: NCT05435339

Last Updated: 2025-04-22

Results Overview

The occurrence of any of the following toxicities, assessed as related to trial treatment, were considered DLTs: All Grade 5 events, Grade 4 anaphylaxis, infusion-related reactions and neutropenia for ≥7 days, Grade 3/4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, Grade 4 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin elevation/Grade 3 that did not recover to ≤Grade 1 within 14 days, AST or ALT elevations ≥Grade 2 with concomitant bilirubin \>2.0×upper limit of normal with no signs of cholestasis, any Grade 4 immune-related adverse event (irAE), Grade 3 irAEs that did not improve to ≤Grade 1 within 7 days (with exceptions), Grade 4 cytokine release syndrome (CRS), Grade 3 CRS not resolved to ≤Grade 2 within 48 hrs following adequate intervention, any other ≥Grade 3 nonhematological adverse event (AE) during the first GEN1053 treatment cycle (with exceptions), cycle=3 weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Day 1 up to Day 21
• Results posted on: 2025-04-22

Participant Flow

This study was early terminated and only the GEN1053 monotherapy dose escalation was initiated and completed. The study was terminated prior to the start of the Dose Expansion Phase.

Participant milestones

Measure	GEN1053 Dose Level 1 Once Every 3 Weeks (Q3W) Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by intravenous (IV) infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Overall Study STARTED	1	1	3	1	6	3	7	9
Overall Study Received at Least 1 Dose of Study Drug	1	1	3	1	6	3	7	9
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	3	1	6	3	7	9

Reasons for withdrawal

Measure	GEN1053 Dose Level 1 Once Every 3 Weeks (Q3W) Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by intravenous (IV) infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Overall Study Death	1	0	3	1	3	2	4	6
Overall Study Sponsor Decision	0	1	0	0	2	1	2	2
Overall Study Withdrawal by Subject	0	0	0	0	1	0	1	1

Baseline Characteristics

A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy

Baseline characteristics by cohort

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	9 Participants n=24 Participants	19 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	0 Participants n=24 Participants	12 Participants n=42 Participants
Age, Continuous	79 years n=5 Participants	78 years n=7 Participants	62.3 years STANDARD_DEVIATION 13.9 • n=5 Participants	57 years n=4 Participants	55.2 years STANDARD_DEVIATION 13.1 • n=21 Participants	66 years STANDARD_DEVIATION 16.1 • n=8 Participants	68.7 years STANDARD_DEVIATION 8.4 • n=8 Participants	57 years STANDARD_DEVIATION 5.7 • n=24 Participants	62.1 years STANDARD_DEVIATION 11.4 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	15 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	21 Participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants	9 Participants n=24 Participants	31 Participants n=42 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	21 Participants n=42 Participants
Region of Enrollment United States of America (The)	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	10 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 21

Population: Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

The occurrence of any of the following toxicities, assessed as related to trial treatment, were considered DLTs: All Grade 5 events, Grade 4 anaphylaxis, infusion-related reactions and neutropenia for ≥7 days, Grade 3/4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, Grade 4 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin elevation/Grade 3 that did not recover to ≤Grade 1 within 14 days, AST or ALT elevations ≥Grade 2 with concomitant bilirubin >2.0×upper limit of normal with no signs of cholestasis, any Grade 4 immune-related adverse event (irAE), Grade 3 irAEs that did not improve to ≤Grade 1 within 7 days (with exceptions), Grade 4 cytokine release syndrome (CRS), Grade 3 CRS not resolved to ≤Grade 2 within 48 hrs following adequate intervention, any other ≥Grade 3 nonhematological adverse event (AE) during the first GEN1053 treatment cycle (with exceptions), cycle=3 weeks.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 1.5 years

Population: Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal safety laboratory parameter finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was defined as an AE occurring or worsening after first dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)	1 Participants	1 Participants	3 Participants	1 Participants	6 Participants	3 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing the pharmacokinetics (PK) of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Clearance (CL) of GEN1053 Cycle 1	2450.0 milliliters (mL)/day	3120.0 milliliters (mL)/day	916.7 milliliters (mL)/day Geometric Coefficient of Variation 30.8	—	594.0 milliliters (mL)/day Geometric Coefficient of Variation 19.7	491.3 milliliters (mL)/day Geometric Coefficient of Variation 35.6	471.7 milliliters (mL)/day Geometric Coefficient of Variation 29.5	567.7 milliliters (mL)/day Geometric Coefficient of Variation 39.1
Clearance (CL) of GEN1053 Cycle 3	—	—	—	—	293.1 milliliters (mL)/day Geometric Coefficient of Variation 19.5	—	244.5 milliliters (mL)/day Geometric Coefficient of Variation 36.0	435.2 milliliters (mL)/day Geometric Coefficient of Variation 27.3

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Volume of Distribution (Vz) of GEN1053 Cycle 1	4300.0 mL	3950.0 mL	6077.1 mL Geometric Coefficient of Variation 17.9	—	6108.9 mL Geometric Coefficient of Variation 34.2	6455.8 mL Geometric Coefficient of Variation 8.1	6808.7 mL Geometric Coefficient of Variation 73.4	7434.6 mL Geometric Coefficient of Variation 70.8
Volume of Distribution (Vz) of GEN1053 Cycle 3	—	—	—	—	5683.6 mL Geometric Coefficient of Variation 36.1	—	5302.1 mL Geometric Coefficient of Variation 9.1	10834.8 mL Geometric Coefficient of Variation 77.5

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Maximum (Peak) Concentration (Cmax) of GEN1053 Cycle 1	0.530 micrograms (μg)/mL	1.570 micrograms (μg)/mL	5.583 micrograms (μg)/mL Geometric Coefficient of Variation 27.187	12.000 micrograms (μg)/mL	16.862 micrograms (μg)/mL Geometric Coefficient of Variation 8.824	60.854 micrograms (μg)/mL Geometric Coefficient of Variation 44.313	124.869 micrograms (μg)/mL Geometric Coefficient of Variation 22.050	218.641 micrograms (μg)/mL Geometric Coefficient of Variation 24.465
Maximum (Peak) Concentration (Cmax) of GEN1053 Cycle 3	—	1.450 micrograms (μg)/mL	—	—	20.970 micrograms (μg)/mL Geometric Coefficient of Variation 11.732	60.400 micrograms (μg)/mL	159.509 micrograms (μg)/mL Geometric Coefficient of Variation 26.510	306.525 micrograms (μg)/mL Geometric Coefficient of Variation 31.455

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Time to Maximum (Peak) Concentration (Tmax) of GEN1053 Cycle 1	0.0620 days	0.0600 days	0.0583 days Geometric Coefficient of Variation 3.5988	0.1390 days	0.0855 days Geometric Coefficient of Variation 65.5230	0.0760 days Geometric Coefficient of Variation 45.9942	0.0826 days Geometric Coefficient of Variation 75.6636	0.0953 days Geometric Coefficient of Variation 60.7249
Time to Maximum (Peak) Concentration (Tmax) of GEN1053 Cycle 3	—	0.1350 days	—	—	0.1023 days Geometric Coefficient of Variation 64.0898	0.1390 days	0.0784 days Geometric Coefficient of Variation 43.4302	0.0746 days Geometric Coefficient of Variation 49.4225

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=5 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=2 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=5 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Predose Trough Concentration (Ctrough) of GEN1053 Cycle 1	0.0250 ug/mL	0.0250 ug/mL	0.1322 ug/mL Geometric Coefficient of Variation 58.7685	—	1.5722 ug/mL Geometric Coefficient of Variation 60.7405	6.0890 ug/mL Geometric Coefficient of Variation 132.2920	24.8853 ug/mL Geometric Coefficient of Variation 4.2283	33.6922 ug/mL Geometric Coefficient of Variation 28.1602
Predose Trough Concentration (Ctrough) of GEN1053 Cycle 3	—	—	—	—	4.3705 ug/mL Geometric Coefficient of Variation 53.5677	—	58.5326 ug/mL Geometric Coefficient of Variation 12.2317	56.3000 ug/mL

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Elimination Half-life (t1/2) of GEN1053 Cycle 1	1.2200 days	0.8750 days	4.5977 days Geometric Coefficient of Variation 13.0224	—	7.1235 days Geometric Coefficient of Variation 53.5614	9.1195 days Geometric Coefficient of Variation 30.0207	10.0111 days Geometric Coefficient of Variation 81.6893	9.0787 days Geometric Coefficient of Variation 100.0112
Elimination Half-life (t1/2) of GEN1053 Cycle 3	—	—	—	—	13.4236 days Geometric Coefficient of Variation 53.5705	—	15.0597 days Geometric Coefficient of Variation 27.0838	17.2624 days Geometric Coefficient of Variation 43.0077

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Measurement (AUClast) of GEN1053 Cycle 1	0.5620 day*ug/mL	1.5300 day*ug/mL	21.8315 day*ug/mL Geometric Coefficient of Variation 30.8860	15.2000 day*ug/mL	86.0185 day*ug/mL Geometric Coefficient of Variation 62.0662	379.6819 day*ug/mL Geometric Coefficient of Variation 41.9278	678.2510 day*ug/mL Geometric Coefficient of Variation 55.6633	1190.8115 day*ug/mL Geometric Coefficient of Variation 69.3078
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Measurement (AUClast) of GEN1053 Cycle 3	—	0.1930 day*ug/mL	—	—	204.3491 day*ug/mL Geometric Coefficient of Variation 19.5536	423.0000 day*ug/mL	1510.1353 day*ug/mL Geometric Coefficient of Variation 51.8536	1985.3056 day*ug/mL Geometric Coefficient of Variation 33.6209

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 (cycles were 3 weeks)

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure. Number analyzed = participants with evaluable data at the specified timepoint.

Venous blood samples were collected for analyzing concentrations of GEN1053.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
AUC From Time Zero Over the Dosing Interval (AUCtau) of GEN1053 Cycle 3	—	—	—	—	203.9020 day*ug/mL Geometric Coefficient of Variation 19.9691	—	1656.9616 day*ug/mL Geometric Coefficient of Variation 36.6222	1842.9867 day*ug/mL Geometric Coefficient of Variation 26.7838
AUC From Time Zero Over the Dosing Interval (AUCtau) of GEN1053 Cycle 1	0.8170 day*ug/mL	1.9200 day*ug/mL	21.8315 day*ug/mL Geometric Coefficient of Variation 30.8860	—	100.5407 day*ug/mL Geometric Coefficient of Variation 19.7816	402.5411 day*ug/mL Geometric Coefficient of Variation 37.4881	835.4647 day*ug/mL Geometric Coefficient of Variation 28.4628	1392.1084 day*ug/mL Geometric Coefficient of Variation 37.2599

SECONDARY outcome

Timeframe: Cycle 1 Day 1 through end of safety follow up (60 days after last dose [cycles were 3 weeks]), up to approximately 1.5 years

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of trial drug and who provided at least 1 evaluable PK sample. Overall number of participants analyzed = participants with evaluable data for the outcome measure.

Venous blood samples were drawn for analysis of ADAs in serum samples.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 1 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 2 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 3 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 4 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 6 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 8 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 10 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 12 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 14 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 16 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 18 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Cycle 20 Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 End of Treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Safety Follow Up 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053 Safety Follow Up 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 1.5 years

Population: Measured in the Full Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

ORR was defined as the number of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) (ie, "responders"), as per local review and according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Objective Response Rate (ORR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 1.5 years

Population: Measured in the Full Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

DCR was defined as the number of participants with CR, PR, or stable disease (SD). CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 mm in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters (nadir) while on study. Data are presented for the number of participants with DCR.

Outcome measures

Measure	GEN1053 Dose Level 1 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 Participants Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 Participants Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 Participants Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 Participants Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 Participants Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Disease Control Rate (DCR)	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to approximately 1.5 years

Population: Measured in the Full Analysis Set (which included all participants who received at least 1 dose of trial drug) in those participants whose confirmed BOR was CR or PR. Participants were analyzed according to the actual trial treatment received. Overall number of participants analyzed = 0 as no participants had a confirmed BOR of CR or PR.

DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death due to any cause in participants whose confirmed BOR was CR or PR.

Outcome measures

Outcome data not reported

Adverse Events

GEN1053 Dose Level 1 Q3W

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

GEN1053 Dose Level 2 Q3W

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

GEN1053 Dose Level 3 Q3W

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

GEN1053 Dose Level 4 Q3W

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

GEN1053 Dose Level 5 Q3W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 3 deaths

GEN1053 Dose Level 6 Q3W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

GEN1053 Dose Level 7 Q3W

Serious events: 0 serious events

Other events: 7 other events

Deaths: 4 deaths

GEN1053 Dose Level 8 Q3W

Serious events: 3 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Measure	GEN1053 Dose Level 1 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 participants at risk Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 participants at risk Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 participants at risk Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 participants at risk Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 participants at risk Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Gastrointestinal disorders Large intestine perforation	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Fatigue	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Immune system disorders Immune system disorder	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Pneumonia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

Other adverse events

Measure	GEN1053 Dose Level 1 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 1 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 2 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 2 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 3 Q3W n=3 participants at risk Participants with malignant solid tumors were treated with dose level 3 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 4 Q3W n=1 participants at risk Participants with malignant solid tumors were treated with dose level 4 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 5 Q3W n=6 participants at risk Participants with malignant solid tumors were treated with dose level 5 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 6 Q3W n=3 participants at risk Participants with malignant solid tumors were treated with dose level 6 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 7 Q3W n=7 participants at risk Participants with malignant solid tumors were treated with dose level 7 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.	GEN1053 Dose Level 8 Q3W n=9 participants at risk Participants with malignant solid tumors were treated with dose level 8 of GEN1053 Q3W by IV infusion. Dose Level 1 was the lowest dose, and doses were increased incrementally up to Dose Level 8, which was the highest dose.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Head injury	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Faeces discoloured	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 2/6 • Number of events 6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	28.6% 2/7 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	44.4% 4/9 • Number of events 10 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Neutrophil count decreased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Eye disorders Eyelid oedema	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Face oedema	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Amylase increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Blood fibrinogen decreased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 2/6 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	57.1% 4/7 • Number of events 5 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	55.6% 5/9 • Number of events 19 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Urinary tract infection	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Fatigue	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	66.7% 2/3 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	44.4% 4/9 • Number of events 9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Skin infection	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Ear and labyrinth disorders Vertigo	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Odynophagia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Psychiatric disorders Bradyphrenia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Vascular disorders Haematoma	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Endocrine disorders Hypothyroidism	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Nasopharyngitis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Blood creatinine increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Asthenia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	42.9% 3/7 • Number of events 5 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Abdominal sepsis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	66.7% 2/3 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Nervous system disorders Paraesthesia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Procalcitonin increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Vascular disorders Hypotension	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Conjunctivitis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Oedema peripheral	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	66.7% 2/3 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Sinusitis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Nausea	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Renal and urinary disorders Haematuria	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Renal and urinary disorders Nocturia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 5 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 2/6 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	66.7% 2/3 • Number of events 7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	28.6% 2/7 • Number of events 5 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	44.4% 4/9 • Number of events 15 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Blood bilirubin increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Pyrexia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 3/9 • Number of events 5 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Chills	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Platelet count decreased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
General disorders Influenza like illness	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Gastrointestinal disorders Constipation	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	28.6% 2/7 • Number of events 4 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Investigations Lipase increased	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Nervous system disorders Dizziness	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	11.1% 1/9 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Cardiac disorders Bradycardia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Nervous system disorders Headache	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	14.3% 1/7 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Infections and infestations Klebsiella urinary tract infection	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/6 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	33.3% 1/3 • Number of events 1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	22.2% 2/9 • Number of events 15 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/1 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	16.7% 1/6 • Number of events 2 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/3 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/7 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.	0.00% 0/9 • Up to approximately 1.5 years Measured in the Safety Analysis Set, which included all participants who received at least 1 dose of trial drug. Participants were analyzed according to the actual trial treatment received.

Additional Information

CLINICAL TRIAL INFORMATION

Genmab

Phone: +45 7020 2728

Email: clinicaltrials@genmab.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place