Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT04052997)

Last Updated: 2024-03-28

Results Overview

ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

117 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2024-03-28

Participant Flow

Participants were enrolled from September 2019 to January 2023 across 9 countries (USA, Canada, Belgium, Czech Republic, France, Hungary, Italy, Spain, UK).

Participants with relapsed or refractory Hodgkin Lymphoma received intravenous (IV) infusions of camidanlumab tesirine.

Participant milestones

Participant milestones
Measure	Camidanlumab Tesirine Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Overall Study STARTED	117
Overall Study Discontinued From Study	117
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Reasons for withdrawal
Measure	Camidanlumab Tesirine Participants received IV infusions of camidanlumab tesirine every 3 weeks (Q3W) at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Overall Study Withdrawal by Subject	17
Overall Study Physician Decision	50
Overall Study Death	43
Overall Study Lost to Follow-up	5
Overall Study Progression of Disease	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Age, Continuous	42.5 Years STANDARD_DEVIATION 16.24 • n=99 Participants
Sex: Female, Male Female	44 Participants n=99 Participants
Sex: Female, Male Male	73 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants
Race/Ethnicity, Customized Asian	3 Participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=99 Participants
Race/Ethnicity, Customized White	101 Participants n=99 Participants
Race/Ethnicity, Customized Other	5 Participants n=99 Participants
Race/Ethnicity, Customized Missing	2 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score ECOG Score 0	64 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score ECOG Score 1	47 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score ECOG Score 2	6 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score ECOG Score 3	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Overall Response Rate (ORR)	82 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data from participants in the All-Treated Population who achieved ether CR or PR by independent reviewer.

DOR defined as the time from the first documentation of tumor response to disease progression or death.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=82 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Duration of Response (DOR)	13.73 Months Interval 7.85 to 14.65

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

CR rate defined as the number of treated participants with a best overall response (BOR) of CR.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
CR Rate	39 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data from participants in the All-Treated Population who achieved CR.

RFS defined as the time from the documentation of CR to disease progression or death.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=39 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Relapse-Free Survival (RFS)	11.07 Months Interval 7.36 to Upper confidence interval was not reached due to lack of events.

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Progression-Free Survival (PFS)	9.13 Months Interval 5.26 to 14.98

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

OS defined as the time from first dose of study drug until death due to any cause.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Overall Survival (OS)	NA Months Median and confidence intervals were not reached due to lack of events.

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Participants receiving HSCT following camidanlumab tesirine, and without any other anticancer therapy in between, other than the therapies preparing for HSCT, were included in this analysis.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)	18 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)	116 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

An SAE is defined as any adverse event (AE) that: * results in death. * is life threatening. * requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE). * results in persistent or significant disability/incapacity. * is a congenital anomaly/birth defect. * important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)	46 Participants

SECONDARY outcome

Timeframe: EOT (up to 3 years)

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine and reported ECOG data at EOT. This population was used in the primary analyses of efficacy and safety.

The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=96 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT) Score 0	43 Participants
Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT) Score 1	37 Participants
Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT) Score 2	12 Participants
Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT) Score 3	4 Participants

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Population: PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=111 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody Cycle 1	825 µg/L Geometric Coefficient of Variation 66.7
Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody Cycle 2	797 µg/L Geometric Coefficient of Variation 62.3

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Cmax of Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 1	0.0170 µg/L Geometric Coefficient of Variation 31.6
Cmax of Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 2	0.0180 µg/L Geometric Coefficient of Variation 38.3

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=114 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Cmax of Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 1	696 µg/L Geometric Coefficient of Variation 66.5
Cmax of Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 2	685 µg/L Geometric Coefficient of Variation 61.7

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=111 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody	4037 day*ug/L Geometric Coefficient of Variation 73.2

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=114 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AUCtau For Camidanlumab Tesirine PBD-Conjugated Antibody	3067 day*ug/L Geometric Coefficient of Variation 65.8

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Population: No data collected for this endpoint.

No data collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=111 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody Cycle 1	489 day*ug/L Geometric Coefficient of Variation 788
Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody Cycle 2	725 day*ug/L Geometric Coefficient of Variation 897

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=114 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AUClast For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 1	345 day*ug/L Geometric Coefficient of Variation 607
AUClast For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 2	497 day*ug/L Geometric Coefficient of Variation 824

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AUClast For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 1	0 day*ug/L Geometric Coefficient of Variation 104
AUClast For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 2	0 day*ug/L Geometric Coefficient of Variation 211

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=2 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody	6473 day*µg/L Geometric Coefficient of Variation 11.9

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=3 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AUCinf For Camidanlumab Tesirine PBD-Conjugated Antibody	5478 day*µg/L Geometric Coefficient of Variation 31.2

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AUCinf For Camidanlumab Tesirine Unconjugated Warhead SG3199	NA day*µg/L Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=2 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Clearance (CL) For Camidanlumab Tesirine Total Antibody	0.556 L/day Geometric Coefficient of Variation 47.9

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=3 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
CL For Camidanlumab Tesirine PBD-Conjugated Antibody	0.733 L/day Geometric Coefficient of Variation 34.7

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
CL For Camidanlumab Tesirine Unconjugated Warhead SG3199	NA L/day Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=55 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Clearance at Steady State (CLss) For Camidanlumab Tesirine Total Antibody	0.874 L/day Geometric Coefficient of Variation 75.6

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=54 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
CLss For Camidanlumab Tesirine PBD-Conjugated Antibody	0.958 L/day Geometric Coefficient of Variation 64.1

SECONDARY outcome

Timeframe: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
CLss For Camidanlumab Tesirine Unconjugated Warhead SG3199	NA L/day Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=6 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody Cycle 1	5.91 day Geometric Coefficient of Variation 68.6
Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody Cycle 2	4.46 day Geometric Coefficient of Variation 24.6

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=6 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
T1/2 For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 1	3.89 day Geometric Coefficient of Variation 17.5
T1/2 For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 2	4.05 day Geometric Coefficient of Variation 26.1

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
T1/2 For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 1	NA day Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.
T1/2 For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 2	NA day Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=6 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody Cycle 1	5.91 L Geometric Coefficient of Variation 68.6
Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody Cycle 2	3.14 L Geometric Coefficient of Variation 44.1

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=6 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Vss For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 1	2.81 L Geometric Coefficient of Variation 24.9
Vss For Camidanlumab Tesirine PBD-Conjugated Antibody Cycle 2	3.17 L Geometric Coefficient of Variation 37.6

SECONDARY outcome

Timeframe: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Vss For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 1	NA L Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.
Vss For Camidanlumab Tesirine Unconjugated Warhead SG3199 Cycle 2	NA L Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Cycle 1 and 2: day 0 to 21

AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody	1.30 ratio Geometric Coefficient of Variation 52.9

SECONDARY outcome

Timeframe: Cycle 1 and 2: day 0 to 21

AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=6 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AI For Camidanlumab Tesirine PBD-Conjugated Antibody	1.04 ratio Geometric Coefficient of Variation 4.00

SECONDARY outcome

Timeframe: Cycle 1 and 2: day 0 to 21

AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=8 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
AI For Camidanlumab Tesirine Unconjugated Warhead SG3199	NA ratio Geometric Coefficient of Variation NA Geometric mean was not quantifiable due to the low level of observations.

SECONDARY outcome

Timeframe: Up to 3 years

Population: All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=117 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Post Dose	2 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

Population: Patient Reported Outcome (PRO) Population: All participants in the all-treated population with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).

Participants were asked to indicate their health state on a VAS with scores ranging from 'the worst health you can imagine' (score 0) to 'the best health you can imagine' (score 100). Participants are asked to mark an "X" on the VAS to indicate their own health and then to report the score in a text box. Positive changes from Baseline represent an an improvement in heath.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=116 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 2	3.6 score on a scale Standard Deviation 14.41
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 3	5.2 score on a scale Standard Deviation 15.14
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 4	4.9 score on a scale Standard Deviation 17.65
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 5	4.6 score on a scale Standard Deviation 19.66
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 6	-1.2 score on a scale Standard Deviation 14.97
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 7	4.5 score on a scale Standard Deviation 11.88
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 8	4.5 score on a scale Standard Deviation 13.24
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 9	3.3 score on a scale Standard Deviation 13.74
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 10	1.3 score on a scale Standard Deviation 7.30
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 11	-0.6 score on a scale Standard Deviation 10.44
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 12	-4.8 score on a scale Standard Deviation 5.31
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 13	-1.7 score on a scale Standard Deviation 2.89
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 14	-1.7 score on a scale Standard Deviation 10.41
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Cycle 15	-3.3 score on a scale Standard Deviation 7.64
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) EOT	-3.1 score on a scale Standard Deviation 20.06

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

Population: PRO Population: All participants in the all-treated population with baseline score (at least one instrument) and at least 1 post-baseline score (in at least one instrument).

The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General \[FACT-G\]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.

Outcome measures

Outcome measures
Measure	Camidanlumab Tesirine n=116 Participants Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 2	-0.45 score on a scale Standard Deviation 4.079
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 3	-0.02 score on a scale Standard Deviation 4.935
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 4	-0.20 score on a scale Standard Deviation 5.384
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 5	-0.13 score on a scale Standard Deviation 4.906
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 6	-1.29 score on a scale Standard Deviation 4.318
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 7	0.39 score on a scale Standard Deviation 3.892
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 8	0.40 score on a scale Standard Deviation 4.419
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 9	-1.38 score on a scale Standard Deviation 6.262
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 10	1.16 score on a scale Standard Deviation 2.374
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 11	1.50 score on a scale Standard Deviation 5.167
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 12	-1.40 score on a scale Standard Deviation 0.548
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 13	0.00 score on a scale Standard Deviation 0.000
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 14	0.00 score on a scale Standard Deviation 0.000
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Cycle 15	0.00 score on a scale Standard Deviation 0.000
Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) EOT	-3.06 score on a scale Standard Deviation 6.802

Adverse Events

Camidanlumab Tesirine

Serious events: 46 serious events

Other events: 116 other events

Deaths: 43 deaths

Serious adverse events

Serious adverse events
Measure	Camidanlumab Tesirine n=117 participants at risk Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Blood and lymphatic system disorders Bone marrow failure	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Blood and lymphatic system disorders Febrile neutropenia	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Cardiac disorders Acute myocardial infarction	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Cardiac disorders Cardiac arrest	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Cardiac disorders Left ventricular failure	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Cardiac disorders Myocardial infarction	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Endocrine disorders Thyroiditis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Diarrhoea	1.7% 2/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Duodenal ulcer	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Duodenal ulcer perforation	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Inguinal hernia	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Intestinal obstruction	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Small intestinal obstruction	0.85% 1/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Pyrexia	2.6% 3/117 • Number of events 3 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Hepatobiliary disorders Drug-induced liver injury	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Cellulitis	1.7% 2/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Pneumonia	1.7% 2/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Adenovirus infection	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Bronchopulmonary aspergillosis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations JC virus infection	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Lung infection	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Pneumonia bacterial	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Pneumonia pneumococcal	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Rash pustular	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Sepsis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Septic shock	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Tooth infection	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Varicella zoster virus infection	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Injury, poisoning and procedural complications Transplant failure	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.7% 2/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Acidosis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Dehydration	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Electrolyte imbalance	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hyperglycaemia	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Myositis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Guillain-Barre syndrome	3.4% 4/117 • Number of events 4 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Epilepsy	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Peripheral motor neuropathy	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Peripheral sensory neuropathy	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Radiculopathy	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Syncope	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Product Issues Device occlusion	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Renal and urinary disorders Acute kidney injury	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Renal and urinary disorders Tubulointerstitial nephritis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.7% 2/117 • Number of events 2 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.6% 3/117 • Number of events 3 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Dermatosis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Eczema	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Parakeratosis	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Vascular disorders Shock haemorrhagic	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Vascular disorders Superior vena cava occlusion	0.85% 1/117 • Number of events 1 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.

Other adverse events

Other adverse events
Measure	Camidanlumab Tesirine n=117 participants at risk Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.
Blood and lymphatic system disorders Anaemia	24.8% 29/117 • Number of events 39 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Blood and lymphatic system disorders Thrombocytopenia	20.5% 24/117 • Number of events 34 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Blood and lymphatic system disorders Neutropenia	16.2% 19/117 • Number of events 29 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Blood and lymphatic system disorders Lymphopenia	15.4% 18/117 • Number of events 26 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Cardiac disorders Sinus tachycardia	6.8% 8/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Endocrine disorders Hypothyroidism	10.3% 12/117 • Number of events 12 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Endocrine disorders Hyperthyroidism	6.8% 8/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Endocrine disorders Thyroiditis	6.0% 7/117 • Number of events 7 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Nausea	27.4% 32/117 • Number of events 40 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Constipation	17.1% 20/117 • Number of events 23 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Diarrhoea	16.2% 19/117 • Number of events 26 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Vomiting	11.1% 13/117 • Number of events 17 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Abdominal pain	10.3% 12/117 • Number of events 14 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Dry mouth	6.0% 7/117 • Number of events 7 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Dyspepsia	5.1% 6/117 • Number of events 6 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Gastrointestinal disorders Stomatitis	5.1% 6/117 • Number of events 6 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Fatigue	38.5% 45/117 • Number of events 53 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Pyrexia	29.9% 35/117 • Number of events 47 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Oedema peripheral	12.0% 14/117 • Number of events 15 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Chills	10.3% 12/117 • Number of events 14 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Asthenia	6.8% 8/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
General disorders Face oedema	6.0% 7/117 • Number of events 7 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Infections and infestations Upper respiratory tract infection	6.0% 7/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Gamma-glutamyltransferase increased	17.1% 20/117 • Number of events 26 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Alanine aminotransferase increased	12.8% 15/117 • Number of events 16 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Aspartate aminotransferase increased	12.0% 14/117 • Number of events 17 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Blood alkaline phosphatase increased	9.4% 11/117 • Number of events 15 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Amylase increased	7.7% 9/117 • Number of events 12 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Lipase increased	7.7% 9/117 • Number of events 11 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Investigations Weight decreased	7.7% 9/117 • Number of events 9 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hypophosphataemia	17.9% 21/117 • Number of events 29 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hyperglycaemia	12.0% 14/117 • Number of events 21 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hypokalaemia	12.0% 14/117 • Number of events 18 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Decreased appetite	10.3% 12/117 • Number of events 12 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 9/117 • Number of events 10 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Hyponatraemia	6.0% 7/117 • Number of events 9 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Metabolism and nutrition disorders Dehydration	5.1% 6/117 • Number of events 7 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Arthralgia	16.2% 19/117 • Number of events 22 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Myalgia	9.4% 11/117 • Number of events 15 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 6/117 • Number of events 9 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Headache	16.2% 19/117 • Number of events 22 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Dizziness	10.3% 12/117 • Number of events 13 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Peripheral sensory neuropathy	6.0% 7/117 • Number of events 7 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Dysgeusia	5.1% 6/117 • Number of events 6 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Nervous system disorders Neuropathy peripheral	5.1% 6/117 • Number of events 6 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Psychiatric disorders Insomnia	13.7% 16/117 • Number of events 17 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Psychiatric disorders Anxiety	5.1% 6/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.7% 16/117 • Number of events 18 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Cough	10.3% 12/117 • Number of events 12 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.5% 10/117 • Number of events 11 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	32.5% 38/117 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Rash	26.5% 31/117 • Number of events 36 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Pruritus	23.9% 28/117 • Number of events 30 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Erythema	12.0% 14/117 • Number of events 19 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Skin and subcutaneous tissue disorders Dry skin	6.0% 7/117 • Number of events 8 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Vascular disorders Hypertension	5.1% 6/117 • Number of events 9 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.
Musculoskeletal and connective tissue disorders Muscular weakness	5.1% 6/117 • Up to 3 years All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.

Additional Information

Clinical Trials Information

ADC Therapeutics SA

Phone: 954-903-7994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60